EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

EndoChoice

Status and phase: Completed; Phase 4

Conditions: Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified

Treatments: Device: Fuse® system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02439502

CD 1978

Details and patient eligibility

About

The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.

Full description

The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).

Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

Fuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.

Fuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects ages 18 at least
• The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance.
• Signed informed consent

Exclusion criteria

• Subjects who are currently enrolled in another clinical study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

open label

Experimental group

Description:

Upper and Lower digestive tract diagnostic. The Fuse® system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse Colonoscopies are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects and for the upper digestive tract (including the esophagus, stomach, and duodenum).

Treatment:

Device: Fuse® system