EndoRotor® Endoscopic Mucosal Resection System for the Colon

• ClinicalTrials.gov Identifier: NCT04203667
• Recruitment Status: Completed
• First Posted: December 18, 2019
• Results First Posted: April 5, 2022
• Last Update Posted: April 5, 2022
• Sponsor: Interscope, Inc.
• Information provided by (Responsible Party): Interscope, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Polyp of Colon; Endoscopic Mucosal Resection; Recurrent Colon Adenoma
• Intervention: Device: EndoRotor Resection
• Enrollment: 66

Participant Flow

Recruitment Details	Participants were recruited at 12 centers in the US and Europe. First participant was enrolled in the study on January 25, 2018 and the last participant was enrolled in the study on June 24, 2020. Of the 80 patients screened for this study, 66 were enrolled and treated with EndoRotor.
Pre-assignment Details	The study was over-enrolled. The protocol required 60 subjects; however, 66 subjects were enrolled and treated of which 62 completed the study.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection.
Period Title: Overall Study
Started [1]	66
Per Protocol Population	45
Completed	62
Not Completed	4
Reason Not Completed
Withdrawal by Subject	1
Lost to Follow-up	1
Death	1
PI left center and never scheduled 90 day follow-up visit.	1
[1] Intent to Treat Population

Baseline Characteristics

Arm/Group Title		EndoRotor Resection Arm
Arm/Group Description		All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection.
Overall Number of Baseline Participants		66
Baseline Analysis Population Description		Patients who were enrolled in the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	66 participants
		69 (9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	66 participants
	Female	39 59.1%
	Male	27 40.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	66 participants
Caucasian/White		49 74.2%
Not Disclosed		16 24.2%
African/Black		1 1.5%
Height; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	66 participants
		168.2 (10.0)
Weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	66 participants
		76.1 (17.6)
Systolic Blood Pressure; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	66 participants
		135.6 (25.2)
Diastolic Blood Pressure; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	66 participants
		76.1 (11.6)

Outcome Measures

1. Primary Outcome

Title	Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
Description	[Not Specified]
Time Frame	Index Procedure through 90 Day Post Procedure Follow-up Visit

Outcome Measure Data

Analysis Population Description

Primary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	45 100.0%

2. Primary Outcome

Title	Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.
Description	[Not Specified]
Time Frame	Index Procedure through 90 Day Post Procedure Follow-up Visit

Outcome Measure Data

Analysis Population Description

The safety analysis will be completed on all subjects who were treated with the EndoRotor device.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection.
Overall Number of Participants Analyzed	66
Measure Type: Number; Unit of Measure: Serious Adverse Events
Total number of serious adverse events in Intent to Treat Population.	5
Delayed Rectal Bleed both mild Relation EndoRotor: probable/possible Relation Proc: Both probable	2
Mucosal Laceration Severe Relation to EndoRotor: Unlikely Relation to Procedure: Possible	1
Single Arterial Bleed Severe Relation to EndoRotor: Not related Relation to Proc. Not related	1
General Infection Moderate Relation to EndoRotor: Not related Relation to Proc. Not related	1

3. Secondary Outcome

Title	Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
Description	[Not Specified]
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	45 100.0%

4. Secondary Outcome

Title	Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
Description	[Not Specified]
Time Frame	90-day follow-up visit

Outcome Measure Data

Analysis Population Description

Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Overall Number of Participants Analyzed	47
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

5. Secondary Outcome

Title	Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.
Description	[Not Specified]
Time Frame	90-day follow-up visit

Outcome Measure Data

Analysis Population Description

Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	21 46.7%

6. Secondary Outcome

Title	Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).
Description	[Not Specified]
Time Frame	90-day follow-up visit

Outcome Measure Data

Analysis Population Description

Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.

Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description:	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Overall Number of Participants Analyzed	45
Overall Number of Units Analyzed; Type of Units Analyzed: Specimens	45
Count of Units; Unit of Measure: Specimens
	45 100.0%

Adverse Events

Time Frame	Index procedure through the 90 day post procedure follow-up visit.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	EndoRotor Resection Arm
Arm/Group Description	All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection. EndoRotor Resection: The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
All-Cause Mortality
	EndoRotor Resection Arm
	Affected / at Risk (%)
Total	1/66 (1.52%)
Serious Adverse Events
	EndoRotor Resection Arm
	Affected / at Risk (%)	# Events
Total	7/66 (10.61%)
Cardiac disorders
Heart Attack † [1]	1/66 (1.52%)	1
Gastrointestinal disorders
Single Arterial Bleed † [2]	1/66 (1.52%)	1
Delayed Bleeding † [3]	1/66 (1.52%)	1
Infections and infestations
General Infection † [4]	1/66 (1.52%)	1
Urinary Tract Infection † [5]	1/66 (1.52%)	1
Injury, poisoning and procedural complications
Mucosal Laceration † [6]	1/66 (1.52%)	1
Delayed Rectal Bleed † [7]	2/66 (3.03%)	2
† Indicates events were collected by systematic assessment; [1] Onset: After discharge prior to 90 days Severity: Severe Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: None Outcome: Death; [2] Onset: Procedure Severity: Severe Relationship EndoRotor: Not Related Relationship Procedure: Related Action Taken: clips and hospitalization Outcome: recovered; [3] Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Mediation, hospitalization, endoscopic hemostasis Recovered; [4] Onset: after discharge prior to 90 day follow-up Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Possible Action taken: Hospitalization and observation Recovered; [5] Onset: After discharge prior to 90 days Severity: Mild Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Hospitalization Recovered; [6] Onset time: Procedure Severity: Severe Relationship to EndoRotor: Unlikely Relationship to Procedure: Possible Action Taken: Clipping and Hospitalization Outcome: Recovered; [7] Onset: Post Procedure / After Discharge Severity: Mild / Mild Relation EndoRotor: Possible / Probable Relation Procedure: Both Probable Action Taken: Both Hospitalization, observation, no intervention needed Outcome: Both Recovered
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	EndoRotor Resection Arm
	Affected / at Risk (%)	# Events
Total	6/66 (9.09%)
Gastrointestinal disorders
Post Polypectomy Syndrome † [1]	1/66 (1.52%)	1
Injury, poisoning and procedural complications
Bleeding † [2]	2/66 (3.03%)	2
Seeping bleed † [3]	2/66 (3.03%)	2
Musculoskeletal and connective tissue disorders
Headache † [4]	1/66 (1.52%)	1
† Indicates events were collected by systematic assessment; [1] Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: not related Relationship to procedure: related Action taken: medication Recovered; [2] Onset: Both Procedure Severity: Both mild Relationship to EndoRotor: Possible / Related Relationship to Procedure: Possible / Related Action: Hot biopsy / Clip Both recovered; [3] Onset: both procedure Severity: both mild Relationship to EndoRotor: both related Relationship to Procedure: both not related Action: both clips Both Recovered; [4] Onset: Post procedure prior to discharge Severity: mild Relationship to EndoRotor: not related Relationship to Procedure: not related Action: Medication Recovered

Limitations and Caveats

COVID pandemic made follow-up at each center difficult or impossible for patients who had a 90 day follow-up from March 2020 and beyond. Most of Europe was on lockdown from this point through June 2021.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Alexis James, Global Director of Clinical Affairs
• Organization: Interscope, Inc.
• Phone: 508-847-9478
• EMail: alexis.james@interscopemed.com

• Responsible Party: Interscope, Inc.
• ClinicalTrials.gov Identifier: NCT04203667
• Other Study ID Numbers: CLIN-0001
• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Results First Submitted: August 31, 2021
• Results First Posted: April 5, 2022
• Last Update Posted: April 5, 2022