An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorUniversity Children's Hospital, Zurich
About this trial
The goal of this study is to find out if using the BougieCap device is a safe and effective way to stretch narrow areas in the esophagus (food pipe) in children. The main questions this study wants to answer are:
* Does the BougieCap work well to treat narrow areas in the esophagus comparing with other methods to widen these narrow areas? * Is BougieCap easy to use and does it cause fewer problems or discomfort for children?
Researchers will compare two groups: one using the BougieCap, and the other using traditional methods like balloon dilation, to see which one works better and is safer.
Participants will:
* Answer questions about their symptoms before treatment, 24 hours after, and 14 days later. * Complete these questions during regular hospital visits or over the phone for the final check-up.
This study does not involve any extra risks or burdens for the participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age under 18 years of age
Indication for endoscopic esophageal dilation
Benign stenosis
Written Informed Consent signed by the subject and/or parent/legal representative (if applicable)
Disqualifiers
Stenosis that cannot be treated endoscopically
Malignant esophageal strictures
Contraindications and limitations of the MD as described in the instructions for use
Trial design
Design model
Parallel
Treatments tested in this trial
BougieCap
DeviceThe BougieCap is attached to the tip of the endoscope, offers direct visual and tactile control and the endoscope acts as a carrier of the radial and longitudinal force vectors for the dilation.
Savary-Bougie (A) or balloon dilation (B)
DeviceA: In the Savary- Bougie treatment, dilators of different sizes are advanced to dilate the stenosis. The same procedure is then repeated with the next larger dilator, with the position of the dilator being checked radiologically each time. B: In the case of balloon dilation, a balloon is inserted and inflated at the level of the stenosis. Depending on the age of the child and possibly also the etiology of the stenosis, different balloons sizes are applied, which are then maintained inflated for about one until three minutes and the respective pressure. This procedure could take place under endoscopic or radiological control.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Study Group 1: BougieCapExperimental treatment 1 intervention
Group B: Study Group 2: Standard treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Successful dilation
Satisfactory dilation of the stenosis according to the operator
Time frame
Directly after the interventionSponsors and contacts
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Source ClinicalTrials.gov