Status:
TERMINATED
Single Arm Post-marketing Study of SC20 Colonoscope
Lead Sponsor:
Invendo Medical GmbH
Conditions:
Gentle Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Any indication for colonoscopy
- Willing to give informed consent
- Willing to consume 2-4 liters of bowel prep
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02279836
Start Date
October 1 2014
End Date
January 1 2016
Last Update
February 4 2015
Active Locations (3)
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1
Bellevue Hospital Center
New York, New York, United States, 10016
2
NYU Langone Medical Center Ambulatory care
New York, New York, United States, 10016
3
New York Presbyterian Columbia University Medical Center
New York, New York, United States, 10032