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Balloon Dilation Under Portable X-ray System in the Treatment of Pharyngo-oesphageal Strictures

NCT06846801 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-26

No results posted yet for this study

Summary

The aim of our study is to evaluate the outcomes (efficacy and safety) and to present our experience in X-DR portable x-ray system guided endoscopic balloon dilatation in the treatment of pharyngo-oesophageal strictures as an alternative procedure to the videofluroscopic guided maneuver.

Conditions

  • Pharyngo-oesphageal Strictures

Interventions

PROCEDURE

Balloon Dilation Under Portable X-ray System

* All the esophageal dilation procedures will be performed using rigid hypopharyngoscope and / or oesophagoscope with endotracheal intubation under general anesthesia by experienced surgical and anesthesia team. * The rigid hypopharyngoscope / oesophagoscope (Storz, germany) will be introduced through the mouth to whole through examination to localize the site of the stenosis then a contrast material will be injected via the endoscope and picture taken with X-DR portable x-ray system. * After that a guide wire 0.035mm will be passed through the endoscope till the stomach. The guide wire site will be confirmed by with X-DR portable x-ray system and then a suitable size balloon catheter will be passed over the guide wire (Boston Scientific, Cork, Ireland), then the balloon catheter will be advanced through the stricture confirmed by taking a photo by the x-ray system. The balloon will be inflated with radiopaque contrast solution using EncoreTM 26 inflation device.

Sponsors & Collaborators

  • Mohammed Elrabie Ahmed

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846801 on ClinicalTrials.gov