An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Esophageal StenosisEsophageal Dilation
Interventions
DEVICE

BougieCap

The 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.

DEVICE

Savary-Bougie (A) or balloon dilation (B)

"A: 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."

Trial Locations (3)

4056

RECRUITING

Universitäts-Kinderspital beider Basel, Basel

8032

RECRUITING

University Children's Hospital Zurich, Zurich

00161

RECRUITING

Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,, Rome

All Listed Sponsors
lead

University Children's Hospital, Zurich

OTHER