Skip to content

Bougiecap for Treatment of Benign Stenosis in GI Tract

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03349021
Enrollment
50
Registered
2017-11-21
Start date
2018-02-01
Completion date
2018-09-01
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagostenosis

Keywords

esophagus, stenosis, bougienage

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.

Interventions

DEVICEBougiecap

Treatment of esophagel Stenosis by Bougiecap

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group interventional study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficient bougienage with BougieCapDay 0 (directly) after endoscopyTo measure the effect of bougienage a passage with the endoscope should be possible.after Treatment with the BougieCap (5mm Endoscope, 10mm endoscope)

Secondary

MeasureTime frameDescription
Qol dysphagiaDay 0 before endoscopy and Day14 after treatmentEvaluation of life Quality by a 13 questions questionnaire. Clinical symptoms of dysphagia and General Quality of life are evaluated

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026