Single Arm Post-marketing Study of SC20 Colonoscope (SC20 Scope)

February 3, 2015 updated by: Invendo Medical GmbH

Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old

The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points:

  1. The diagnostic performance of the device including polyp and adenoma detection rates;
  2. The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
  3. Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital Center
      • New York, New York, United States, 10032
        • New York Presbyterian Columbia University Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Medical Center Ambulatory care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any indication for colonoscopy
  • Willing to give informed consent
  • Willing to consume 2-4 liters of bowel prep

Exclusion Criteria:

  • An age younger than 18 years
  • Congestive heart failure
  • Renal insufficiency
  • Intestinal obstruction
  • Any acute life-threatening condition (in the opinion of the investigator)
  • Current pregnancy
  • Abdominal surgery in the past 6 months
  • Bleeding disorders
  • Inability to provide informed consent
  • Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm post-marketing Study
SC20 Colonoscope and Colonoscopy System For Colonoscopy
Device: SC20 Colonoscope
Single Arm Post-Marketing Study of SC20 Colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
Time Frame: average 6 to 12 months
average 6 to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
2. Detection of polyps, adenomas and other lesions in all individuals
Time Frame: average 6 to 12 months
average 6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invendo Medical GmbH

Investigators

  • Principal Investigator: Adam Goodman, MD, NYU Langone Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Invendo s14-01040

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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