Bougiecap for Treatment of Benign Stenosis in GI Tract

Esophagostenosis Clinical Trial

Official title:

The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349021
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: October 2018
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis
• Esophagostenosis

Intervention

Device:
• Bougiecap
Treatment of esophagel Stenosis by Bougiecap

Locations

Country	Name	City	State
Germany	Marienhospital	Essen
Germany	Universitätklinikum Ulm	Ulm	Baden-Württemberg
United Kingdom	Southhamptan University Hospital	Southhampton

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

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