Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03349021
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2017-11-14
Brief Title:
Bougiecap for Treatment of Benign Stenosis in GI Tract
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
The Bougiecap a New Method for Treatment of Benign Stenosis in GI Tract
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None