Clinical trial NCT03349021: Bougiecap for Treatment of Benign Stenosis in GI Tract
Official title: The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagostenosis
Keywords: esophagus
stenosis
bougienage
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group interventional study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficient bougienage with BougieCap
timeFrame: Day 0 (directly) after endoscopy
Secondary outcomes:
measure: Qol dysphagia
timeFrame: Day 0 before endoscopy and Day14 after treatment
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätklinikum Ulm
state: Baden-Württemberg
city: Essen
country: Germany
facility: Marienhospital
city: Southhampton
country: United Kingdom
facility: Southhamptan University Hospital
Study officials:
affiliation: Head of Endoscopy
name: Alexander Meining, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.