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.

Tracking Information

• First Submitted Date: December 16, 2019
• First Posted Date: December 18, 2019
• Results First Submitted Date: August 31, 2021
• Results First Posted Date: April 5, 2022
• Last Update Posted Date: April 5, 2022
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: April 5, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2021)

• 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. [ Time Frame: Index Procedure through 90 Day Post Procedure Follow-up Visit ]
• 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. [ Time Frame: Index Procedure through 90 Day Post Procedure Follow-up Visit ]

Original Primary Outcome Measures (submitted: December 16, 2019)

Adverse Events [ Time Frame: 90-day follow-up period ]

Technical Success, defined as the ability of the EndoRotor device to resect recurrent flat or sessile colorectal lesions without concomitant use of other resection modalities for mucosectomy and no definitely or probably device-related serious adverse events (SAEs) throughout the 90-day follow-up period.

Current Secondary Outcome Measures (submitted: March 28, 2022)

• Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. [ Time Frame: Index Procedure ]
• Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. [ Time Frame: 90-day follow-up visit ]
• 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. [ Time Frame: 90-day follow-up visit ]
• Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). [ Time Frame: 90-day follow-up visit ]

Original Secondary Outcome Measures (submitted: December 16, 2019)

• Efficacy of Resection [ Time Frame: 90-day follow-up period ]
  Completeness, in percentage, of resection based on endoscopy film and/or photographs and in addition to diagnostic assessment of specimen graded by the independent pathologist.
• Stricture Efficacy [ Time Frame: 90-day follow-up period ]
  Presence of colon stenosis based on endoscopy film and/or photographs.
• Rate of persistence [ Time Frame: 90-day follow-up period ]
  Rate of persistence of disease at the location of resection at 90 days.
• Histology [ Time Frame: 90-day follow-up period ]
  Histologic assessment of the diagnostic value of the collected specimens.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EndoRotor® Endoscopic Mucosal Resection System for the Colon
• Official Title: Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

Brief Summary

The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

• Detailed Description: Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Polyp of Colon
• Endoscopic Mucosal Resection
• Recurrent Colon Adenoma

Intervention

Device: 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.

Study Arms

EndoRotor Resection Arm

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.

Intervention: Device: EndoRotor Resection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2021): 66
• Original Estimated Enrollment (submitted: December 16, 2019): 60
• Actual Study Completion Date: April 5, 2020
• Actual Primary Completion Date: April 5, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects aged ≥18 to ≤85 years.
2. At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
3. Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
4. Favorable anatomy that allows the investigator to access the lesion.
5. Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
6. Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.

Exclusion Criteria:

1. Inability to give informed consent.
2. Subject age is <18 years of age or >85 years of age.
3. Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
4. Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
5. Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
6. Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.
7. Inability to undergo a procedure under propofol sedation or General Anesthesia.
8. Female patients who are known to be pregnant.
9. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
10. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
11. Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.
12. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, United States

Administrative Information

• NCT Number: NCT04203667
• Other Study ID Numbers: CLIN-0001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Interscope, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Interscope, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guido Costamagna, MD; Principal Investigator

• PRS Account: Interscope, Inc.
• Verification Date: April 2022