EndoRotor® Endoscopic Mucosal Resection System for the Colon
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| ClinicalTrials.gov Identifier: NCT04203667 |
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Recruitment Status :
Completed
First Posted : December 18, 2019
Results First Posted : April 5, 2022
Last Update Posted : April 5, 2022
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Sponsor:
Interscope, Inc.
Information provided by (Responsible Party):
Interscope, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polyp of Colon Endoscopic Mucosal Resection Recurrent Colon Adenoma | Device: EndoRotor Resection | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 66 participants |
| 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 |
| 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 |
| Actual Study Start Date : | April 18, 2018 |
| Actual Primary Completion Date : | April 5, 2020 |
| Actual Study Completion Date : | April 5, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects aged ≥18 to ≤85 years.
- At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
- Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
- Favorable anatomy that allows the investigator to access the lesion.
- Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
- Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
Exclusion Criteria:
- Inability to give informed consent.
- Subject age is <18 years of age or >85 years of age.
- Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
- Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
- 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.)
- Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.
- Inability to undergo a procedure under propofol sedation or General Anesthesia.
- Female patients who are known to be pregnant.
- 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).
- Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203667
Locations
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| France | |
| Centre Hospitalier Universitaire (CHU) | |
| Angers, France | |
| Hopital Edouard Herriot | |
| Lyon, France, 69003 | |
| Cochin University Hospital | |
| Paris, France, 75014 | |
| Germany | |
| Allgemeines Krankenhaus Celle | |
| Celle, Germany, 29223 | |
| Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf | |
| Hamburg, Germany | |
| Catholic Clinic Mainz | |
| Mainz, Germany | |
| Sana Klinikum Offenbach | |
| Offenbach, Germany, 63069 | |
| Italy | |
| Fondazione Poliambulanza Istituto Ospedaliero | |
| Brescia, Italy, 25124 | |
| Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica | |
| Rome, Italy, 00168 | |
| Humanitas Research Hospital & Humanitas University | |
| Rozzano, Italy, 20089 | |
Sponsors and Collaborators
Interscope, Inc.
Investigators
| Principal Investigator: | Guido Costamagna, MD | Principal Investigator |
Study Documents (Full-Text)
Documents provided by Interscope, Inc.:
Documents provided by Interscope, Inc.:
Study Protocol and Statistical Analysis Plan [PDF] April 19, 2019
| Responsible Party: | Interscope, Inc. |
| ClinicalTrials.gov Identifier: | NCT04203667 |
| Other Study ID Numbers: |
CLIN-0001 |
| First Posted: | December 18, 2019 Key Record Dates |
| Results First Posted: | April 5, 2022 |
| Last Update Posted: | April 5, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Additional relevant MeSH terms:
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Adenoma Colonic Polyps Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Intestinal Polyps Polyps Pathological Conditions, Anatomical |