Bougiecap for Treatment of Benign Stenosis in GI Tract

Not Applicable

Completed

• Conditions: Esophagostenosis
• Interventions: Device: Bougiecap

• Registration Number: NCT03349021
• Lead Sponsor: University of Ulm

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-02-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-09-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bougiecap	Bougiecap	Treatment with Bougiecap instead of Savary Bougie

Primary Outcome Measures

Name	Time	Method
Efficient bougienage with BougieCap	Day 0 (directly) after endoscopy	To measure the effect of bougienage a passage with the endoscope should be possible.after Treatment with the BougieCap (5mm Endoscope, 10mm endoscope)

Secondary Outcome Measures

Name	Time	Method
Qol dysphagia	Day 0 before endoscopy and Day14 after treatment	Evaluation of life Quality by a 13 questions questionnaire. Clinical symptoms of dysphagia and General Quality of life are evaluated

Trial Locations

Locations (3)

Marienhospital; 🇩🇪 Essen, Germany

Southhamptan University Hospital; 🇬🇧 Southhampton, United Kingdom

Universitätklinikum Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany