Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-02-01
2018-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bougiecap
Treatment with Bougiecap instead of Savary Bougie
Bougiecap
Treatment of esophagel Stenosis by Bougiecap
Interventions
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Bougiecap
Treatment of esophagel Stenosis by Bougiecap
Eligibility Criteria
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Inclusion Criteria
* indication for endoscopic treamtent of stenosis
Exclusion Criteria
* malignancy based Stenosis
* no indication for endoscopic treamtent
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Alexander Meining
Head of Endoscopy
Principal Investigators
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Alexander Meining, Prof.
Role: PRINCIPAL_INVESTIGATOR
Head of Endoscopy
Locations
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Universitätklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Marienhospital
Essen, , Germany
Southhamptan University Hospital
Southhampton, , United Kingdom
Countries
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References
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Walter B, Schmidbaur S, Rahman I, Albers D, Schumacher B, Meining A. The BougieCap - a new method for endoscopic treatment of complex benign esophageal stenosis: results from a multicenter study. Endoscopy. 2019 Sep;51(9):866-870. doi: 10.1055/a-0959-1535. Epub 2019 Jul 23.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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