Single Arm Post-marketing Study of SC20 Colonoscope
- Conditions
- Gentle Colonoscopy
- Interventions
- Device: SC20 Colonoscope
- Registration Number
- NCT02279836
- Lead Sponsor
- Invendo Medical GmbH
- 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.).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Any indication for colonoscopy
- Willing to give informed consent
- Willing to consume 2-4 liters of bowel prep
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm post-marketing Study SC20 Colonoscope SC20 Colonoscope and Colonoscopy System For Colonoscopy
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 2. Detection of polyps, adenomas and other lesions in all individuals average 6 to 12 months
Trial Locations
- Locations (3)
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