PowerSpiral Enteroscopy Performance and Safety

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

Detailed Description
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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.

Official Title
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PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy

Conditions
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Small Bowel Disease

Intervention / Treatment
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* Device: Motorized Spiral enteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy Written informed consent Exclusion Criteria: Contraindications for endoscopy because of comorbidities Unable to provide written informed consent Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion Pregnant patients Health status: American Society of Anesthesiologists (ASA) class >3 Inability to tolerate Propofol sedation or general anesthesia for any reason

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>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 | Device: Motorized Spiral enteroscopy<br>* Small-bowel enteroscopy for diagnosis and intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic yield of motorized spiral enteroscopy | Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy | 2 days | 
| The therapeutic yield of motorized spiral enteroscopy | Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy | 2 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motorized Spiral enteroscopy, Device-assisted enteroscopy