PowerSpiral Enteroscopy Performance and Safety

Completed

• Conditions: Small Bowel Disease
• Interventions: Device: Motorized Spiral enteroscopy

• Registration Number: NCT04884113
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.

Detailed Description

Background and Aims:

Motorized Spiral enteroscopy is a recent advancement in enteroscopy. Data are scarce on the utility and safety of the motorized spiral enteroscopy. No data is available on the utility of this technique in patients with altered gastrointestinal (GI) anatomy.

This study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (TER) in patients undergoing enteroscopy for suspected small bowel disease including those with altered GI anatomy.

Methods: A multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Primary Completion: 2021-12-30
• Study Completion: 2022-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Age 18 years and older
2. Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
3. Written informed consent

Exclusion Criteria

1. Contraindications for endoscopy because of comorbidities
2. Unable to provide written informed consent
3. Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure
4. Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion
5. Pregnant patients
6. Health status: American Society of Anesthesiologists (ASA) class >3
7. Inability to tolerate Propofol sedation or general anesthesia for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Motorized Spiral Enteroscopy	Motorized Spiral enteroscopy	Procedure: Motorized Spiral Enteroscopy: PowerSpiral enteroscope will be inserted and advanced with the assistance of motorized spiral rotation, After reaching the point of maximum insertion, cecum or if no further advancement of the enteroscope can be achieved, the enteroscope will be withdrawn using motorized counter-clockwise spiral rotation. When no total enteroscopy is reached, submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde enteroscopy is then performed in the same session or at second session

Primary Outcome Measures

Name	Time	Method
The therapeutic yield of motorized spiral enteroscopy	2 days	Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy
The diagnostic yield of motorized spiral enteroscopy	2 days	Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy

Secondary Outcome Measures

Name	Time	Method
Technical success	2 days	Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy
Total enteroscopy rate	2 days	Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy
Adverse events	7 days	Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy
Total procedural time	2 days	The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy
Depth of maximum insertion into the small bowel	2 days	Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy

Trial Locations

Locations (5)

St Antonius hospital; 🇳🇱 Utrecht, Netherlands

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands