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NCT04895254 Clinical Trial

Colonoscopy Using Motorized Spiral Enteroscope

Colon Disease Clinical Trial

Official title:
Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04895254
Other study ID # W2021.204
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date May 31, 2022

Study information
Verified date June 2022
Source St. Antonius Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Diagnostic colonoscopy
The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.
Procedure:
• Therapeutic colonoscopy
The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy

Locations
Country Name City State
Netherlands University Medical Centre Groningen Groningen
Netherlands St Antonius hospital Nieuwegein

Sponsors (1)
Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies achieving cecum intubation in difficult colons during procedure
Primary evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies Registering adverse events 7 days
Secondary Endoscopic mucosal resection Performing endoscopic mucosal resection on polyps during procedure
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