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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279836
Recruitment Status : Terminated (Study was stopped due to the expected introduction of a next product generation.)
First Posted : October 31, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gentle Colonoscopy Device: SC20 Colonoscope Phase 4

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.).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 2. Detection of polyps, adenomas and other lesions in all individuals [ Time Frame: average 6 to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279836


Locations
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United States, New York
Bellevue Hospital Center
New York, New York, United States, 10016
NYU Langone Medical Center Ambulatory care
New York, New York, United States, 10016
New York Presbyterian Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Invendo Medical GmbH
Investigators
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Principal Investigator: Adam Goodman, MD NYU Langone Medical Center

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Responsible Party: Invendo Medical GmbH
ClinicalTrials.gov Identifier: NCT02279836    
Other Study ID Numbers: Invendo s14-01040
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Invendo Medical GmbH:
Patients with any indication for colonoscopy in the U.S.A.