Colonoscopy Using Motorized Spiral Enteroscope

NCT04895254 | Completed

• 1 other identifier: W2021.204
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Disease

Keywords

Motorized Spiral enteroscopy; colonoscopy

Outcome Measures

Primary Outcomes (2)

• evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies

  achieving cecum intubation in difficult colons

  during procedure

• evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies

  Registering adverse events

  7 days

Secondary Outcomes (1)

• Endoscopic mucosal resection

  during procedure

Study Arms (1)

Experimental: Motorized spiral Enteroscopy

Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope.

Device: Diagnostic colonoscopy; Procedure: Therapeutic colonoscopy

Interventions

Diagnostic colonoscopy DEVICE

The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.

Experimental: Motorized spiral Enteroscopy

Therapeutic colonoscopy PROCEDURE

The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy

Experimental: Motorized spiral Enteroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with failed colonoscopies using the conventional standrad colonoscopy devices.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (2)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

St Antonius hospital

Nieuwegein, 3430 EM, Netherlands

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Abdulbaqi Al-Toma, Ph.D.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: May 25, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)