Single Arm Post-marketing Study of SC20 Colonoscope | NCT02279836

Studies
Single Arm Post-marketing Study of SC20 Colonoscope

NCT02279836

Sponsor

Invendo Medical GmbH

Status

Terminated

Last Update Posted

Feb 4, 2015Estimated

Enrollment

2Actual

Phase

Phase 4

Conditions

Gentle Colonoscopy

Interventions

SC20 Colonoscope

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to the expected introduction of a next product generation.

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Oct 28, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

The diagnostic performance of the device including polyp and adenoma detection rates;
The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
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.).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm post-marketing Study	Other	SC20 Colonoscope and Colonoscopy System For Colonoscopy	Device: SC20 Colonoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SC20 Colonoscope	Device	Single Arm Post-Marketing Study of SC20 Colonoscope	Single arm post-marketing Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
2. Detection of polyps, adenomas and other lesions in all individuals		average 6 to 12 months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Goodman, MD	NYU Langone Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bellevue Hospital Center		New York	New York	10016	United States
NYU Langone Medical Center Ambulatory care