Single Arm Post-marketing Study of SC20 Colonoscope

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02279836

Acronym

SC20 Scope

Enrollment

Registered

2014-10-31

Start date

2014-10-31

Completion date

2016-01-31

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gentle Colonoscopy

Keywords

Patients with any indication for colonoscopy in the U.S.A.

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.).

Interventions

DEVICESC20 Colonoscope

Single Arm Post-Marketing Study of SC20 Colonoscope

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026