Clinical trial NCT03652285: UAS-RBS: a Safety Study
Official title: Universal Partially Covered Removable Self-Expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS): a Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Benign Strictures
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of all Adverse Device Effects
timeFrame: 6 months
measure: Technical stent placement success
timeFrame: Day 0
measure: Full deployment of stent
timeFrame: Day 0
measure: Technical stent removal success
timeFrame: up to 6 months
Secondary outcomes:
measure: SAE during the period after stent removal
timeFrame: 6 months post retrieval
measure: Number of re-interventions
timeFrame: within 12 months following stent placement
measure: Change of dysphagia score (Dakkak and Bennett score of Dysphagia)
timeFrame: Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
measure: Patient's satisfaction with the therapy
timeFrame: week 1, month 1, 2, 3, 6, 9, 12 after implantation
measure: Patient's report of pain
timeFrame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
measure: Quality Of Life SF36 questionnaire
timeFrame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: CUB Hopital erasme
Study officials:
References: