Esophagostenosis Clinical Trial
Official title:
The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract
Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.
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.
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