UAS-RBS: a Safety Study

Not Applicable

Completed

• Conditions: Refractory Benign Strictures
• Interventions: Device: Esophageal stent implantation; Device: Stent removal

• Registration Number: NCT03652285
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Refractory strictures are defined as benign esophageal strictures who do not achieve acceptable symptom relief despite an intensive dilation schedule. Considering the failure of balloon or mechanical dilation other techniques such as intralesional injection of corticosteroids or stents placement were developed.

Self-expandable metal stents, plastic stents and biodegradable stents are also used in that indication. In a meta-analysis of 18 studies with 444 patients, clinical success was achieved in 41 percent of patients. Stent migration occurred in 29 percent of patients, and adverse events occurred in 21 percent.

A self-expending nitinol stent has been design to reduce the migration risk. The stent is partially covered on both extremities, allowing the formation of small hyperplasia in the middle part of the stent. This design with the inner sheet (usually, when using fully covered stents, the sheet is outside) allows formation of hyperplasia (therefore reducing the risk of migration) but partly controlled by the inner sheet to reduce the risk of lumen occlusion. By this design, the balance between hyperplasia formation to avoid the risk of migration and reducing the risk of lumen occlusion could be entailed stable esophageal calibration.

The UAS-RBS system is a reversible procedure to treat Refractory Benign Esophageal Strictures through stent implantation. Above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.

Study Timeline

• Study Start: 2018-03-27
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Technical stent placement success	Day 0	Ability to deploy the UAS-RBS in satisfactory position across the stricture
Full deployment of stent	Day 0	Endoscopic visualization
Incidence of all Adverse Device Effects	6 months	Serious adverse event (SAE) during the period of stent implantation
Technical stent removal success	up to 6 months	Ability to remove the stent without complications

Secondary Outcome Measures

Name	Time	Method
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	scored by a visual analog scale (0 worse - 10 best)
Patient's report of pain	before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation	scored by a visual analog scale (0 worse - 10 best)
Quality Of Life SF36 questionnaire	before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation	SF36

Trial Locations

Locations (1)

CUB Hopital erasme; 🇧🇪 Anderlecht, Belgium