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Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.
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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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50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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