UAS-RBS: a Safety Study

NCT03652285 | Completed

• 1 other identifier: P2017/543
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. This study aims at evaluating the safety of this new device.

Conditions

Refractory Benign Strictures

Outcome Measures

Primary Outcomes (4)

• Incidence of all Adverse Device Effects

  Serious adverse event (SAE) during the period of stent implantation

  6 months

• Technical stent placement success

  Ability to deploy the UAS-RBS in satisfactory position across the stricture

  Day 0

• Full deployment of stent

  Endoscopic visualization

  Day 0

• Technical stent removal success

  Ability to remove the stent without complications

  up to 6 months

Secondary Outcomes (6)

• SAE during the period after stent removal

  6 months post retrieval

• Number of re-interventions

  within 12 months following stent placement

• Change of dysphagia score (Dakkak and Bennett score of Dysphagia)

  Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation

• Patient's satisfaction with the therapy

  week 1, month 1, 2, 3, 6, 9, 12 after implantation

• Patient's report of pain

  before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation

Study Arms (1)

Esophageal stent implantation (UAS-RBS implantation)

EXPERIMENTAL

Esophageal stent implantation (UAS-RBS implantation) at J0, removal after 6 months and follow-up for 6 months

Device: Esophageal stent implantation; Device: Stent removal

Interventions

Esophageal stent implantation DEVICE

An upper endoscopy will be performed with the use of fluoroscopy. Depending on the size of the stricture a dilation can be performed prior to the stent deployment. Otherwise, the stent will be deployed over a guidewire, under fluoroscopy. After, the gastroscopy will go through the esophagus to check for the stent deployment, or any complications. An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened. The patient will be kept overnight, with liquid food for 3 days and under PPI until one month after the stent placement.

Esophageal stent implantation (UAS-RBS implantation)

Stent removal DEVICE

Six months after implantation, the removal of the stent will be performed. Patient will undergo a first endoscopy under general anesthesia for the placement of a FCSEMS. Then, depending on the importance of the hyperplasia, removal of both stents, under general anesthesia, will be done after 7 to 10 days.

Esophageal stent implantation (UAS-RBS implantation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benign Esophageal Refractory Stricture no more than 40 mm in length.
• More than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months.
• Last dilation to 16 mm no more than 6 months before study procedure.
• Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement.
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if:

• Stricture within 2 cm of the upper esophageal sphincter.
• Dysphagia related to motility disorder.
• Planned adjuvant radiation therapy post esophagectomy.
• Esophageal stent in place.
• Active erosive esophagitis.
• Sensitivity to any components of the stent or delivery system.
• Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
• Currently enrolled in another clinical trial.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

CUB Hopital erasme

Anderlecht, 1070, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As a proof of concept, feasibility study - First In Man Study (FIM). The study will enroll 10 patients and an additional 10% of patients to compensate for potential attrition during follow-up, resulting in a sample size of 11 patients.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 29, 2018
• Study Start: March 27, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)