- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203667
EndoRotor® Endoscopic Mucosal Resection System for the Colon
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Angers, France
- Centre Hospitalier Universitaire (Chu)
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Lyon, France, 69003
- Hôpital Edouard Herriot
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Paris, France, 75014
- Cochin University Hospital
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Celle, Germany, 29223
- Allgemeines Krankenhaus Celle
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Hamburg, Germany
- Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf
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Mainz, Germany
- Catholic Clinic Mainz
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Offenbach, Germany, 63069
- Sana Klinikum Offenbach
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Brescia, Italy, 25124
- Fondazione Poliambulanza Istituto Ospedaliero
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Rome, Italy, 00168
- Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica
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Rozzano, Italy, 20089
- Humanitas Research Hospital & Humanitas University
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: 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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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Index Procedure through 90 Day Post Procedure Follow-up Visit
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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
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Index Procedure through 90 Day Post Procedure Follow-up Visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
Time Frame: Index Procedure
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Index Procedure
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Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
Time Frame: 90-day follow-up visit
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90-day follow-up visit
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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
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90-day follow-up visit
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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
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90-day follow-up visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guido Costamagna, MD, Principal Investigator
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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