Colonoscopy Using Motorized Spiral Enteroscope

Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study

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

Study Overview

• Status: Completed
• Conditions: Colon Disease
• Intervention / Treatment: Device: Diagnostic colonoscopy; Procedure: Therapeutic 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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Centre Groningen
  • Nieuwegein, Netherlands, 3430 EM
    • St Antonius Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: Motorized spiral Enteroscopy; Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic mucosal resection	Performing endoscopic mucosal resection on polyps	during procedure

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Abdulbaqi Al-Toma, Ph.D., St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2021
• Primary Completion (ACTUAL): May 31, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; Motorized Spiral enteroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: W2021.204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No