Esophagostenosis Clinical Trial
Official title:
The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract
NCT number | NCT03349021 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2018 |
Est. completion date | September 1, 2018 |
Verified date | October 2018 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 1, 2018 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Marienhospital | Essen | |
Germany | Universitätklinikum Ulm | Ulm | Baden-Württemberg |
United Kingdom | Southhamptan University Hospital | Southhampton |
Lead Sponsor | Collaborator |
---|---|
University of Ulm |
Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |