Single Arm Post-marketing Study of SC20 Colonoscope

NCT ID: NCT02279836

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

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.).

Conditions

Gentle Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Single arm post-marketing Study

SC20 Colonoscope and Colonoscopy System For Colonoscopy

Group Type: OTHER

SC20 Colonoscope

Intervention Type: DEVICE

Single Arm Post-Marketing Study of SC20 Colonoscope

Interventions

SC20 Colonoscope

Single Arm Post-Marketing Study of SC20 Colonoscope

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Invendo Medical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

Bellevue Hospital Center

New York, New York, United States

NYU Langone Medical Center Ambulatory care

New York, New York, United States

New York Presbyterian Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

Invendo s14-01040

Identifier Type: -

Identifier Source: org_study_id