Single Arm Post-marketing Study of SC20 Colonoscope

Gentle Colonoscopy Clinical Trial

— SC20 Scope  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02279836
• Other study ID #: Invendo s14-01040
• Status: Terminated
• Phase: Phase 4
• First received: October 28, 2014
• Last updated: February 3, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2015
• Source: Invendo Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Gentle Colonoscopy

Intervention

Device:
• SC20 Colonoscope
Single Arm Post-Marketing Study of SC20 Colonoscope

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York
United States	New York Presbyterian Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center Ambulatory care	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Invendo Medical GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)		average 6 to 12 months	Yes
Secondary	2. Detection of polyps, adenomas and other lesions in all individuals		average 6 to 12 months	Yes