Bougiecap for Treatment of Benign Stenosis in GI Tract

Study Overview
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Brief Summary
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Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.

Detailed Description
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Benign stenosis in the GI tract are endoscopically treated by using Savary-Gilliard Dilators. This method, although sufficient in its interventional success, provides only haptic control and often requires wire guidance or X-ray imaging for monitoring the position of the stenosis, the dilator and the dilation process. To guarantee the missing optical feedback and enhance the intraprocedural control a conical, clear cap was developed. This single use device is attachable to the front end of an endoscope and provides direct visual evaluation of the mucosal damage and progress of the Bougienage, making x-ray imaging obsolete while resulting in an effective dilation. For the bougienage treatment, the endoscope with the cap on top is inserted into the patient's GI tract and aimed at the stenosis. By pushing the endoscope forward the cone shaped cap expands the mucosal diameter by conversion of longitudinal to radial force vectors. Lateral and frontal openings allow suction and flush during procedure. The clear tapering cap is now to be tested for ist technical feasibility and ability to improve patients' quality of life following treatment. Therefore a quality of life questionnaire (Swal QoL) evaluating the patients' dysphagia is done right before and two weeks after the bougienage and an effective dilation is proved by being able to pass the stenosis with the endoscope after the treatment.

Official Title
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The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract

Conditions
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Esophagostenosis

Intervention / Treatment
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* Device: Bougiecap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: benign Stenosis of the esophagus indication for endoscopic treamtent of stenosis Exclusion Criteria: no informed consent malignancy based Stenosis no indication for endoscopic treamtent

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bougiecap<br>Treatment with Bougiecap instead of Savary Bougie | Device: Bougiecap<br>* Treatment of esophagel Stenosis by Bougiecap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficient bougienage with BougieCap | To measure the effect of bougienage a passage with the endoscope should be possible.after Treatment with the BougieCap (5mm Endoscope, 10mm endoscope) | Day 0 (directly) after endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qol dysphagia | Evaluation of life Quality by a 13 questions questionnaire. Clinical symptoms of dysphagia and General Quality of life are evaluated | Day 0 before endoscopy and Day14 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagus, stenosis, bougienage