Colonoscopy Using Motorized Spiral Enteroscope

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Disease

Intervention / Treatment
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* Device: Diagnostic colonoscopy
* Procedure: Therapeutic colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motorized spiral Enteroscopy<br>Consecutive patients with difficult colonoscopies to be enrolled to achieve total colonoscopy using the motorized spiral enteroscope. | Device: Diagnostic colonoscopy<br>* The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.<br>Procedure: Therapeutic colonoscopy<br>* The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motorized Spiral enteroscopy, colonoscopy