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

Invendo Medical

Status and phase: Terminated; Phase 4

Conditions: Gentle Colonoscopy

Treatments: Device: SC20 Colonoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279836

Invendo s14-01040

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Single arm post-marketing Study

Other group

Description:

SC20 Colonoscope and Colonoscopy System For Colonoscopy

Treatment:

Device: SC20 Colonoscope