Colonoscopy Using Motorized Spiral Enteroscope

Completed

• Conditions: Colon Disease
• Interventions: Device: Diagnostic colonoscopy; Procedure: Therapeutic colonoscopy

• Registration Number: NCT04895254
• Lead Sponsor: St. Antonius Hospital

Brief Summary

The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.

Detailed Description

Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-05-25
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy

Exclusion Criteria

• Age under 18 years
• Known pregnancy
• Poor health status (ASA classification ≥ 4)
• Contraindication for sedation or standard colonoscopy
• Known coagulopathy (INR ≥ 2.0, platelets < 70 /nl) or anticoagulants other than aspirin
• Medical history of chronic inflammatory bowel disease or suspected bowel obstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Motorized spiral Enteroscopy	Diagnostic colonoscopy	Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope.
Experimental: Motorized spiral Enteroscopy	Therapeutic colonoscopy	Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope.

Primary Outcome Measures

Name	Time	Method
evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies	7 days	Registering adverse events
evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies	during procedure	achieving cecum intubation in difficult colons

Secondary Outcome Measures

Name	Time	Method
Endoscopic mucosal resection	during procedure	Performing endoscopic mucosal resection on polyps

Trial Locations

Locations (2)

St Antonius hospital; 🇳🇱 Nieuwegein, Netherlands

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands