- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652285
UAS-RBS: a Safety Study
Universal Partially Covered Removable Self-Expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS): a Safety Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Anderlecht, Belgium, 1070
- CUB Hôpital Erasme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Esophageal stent implantation (UAS-RBS implantation)
Esophageal stent implantation (UAS-RBS implantation) at J0, removal after 6 months and follow-up for 6 months
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of all Adverse Device Effects
Time Frame: 6 months
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Serious adverse event (SAE) during the period of stent implantation
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6 months
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Technical stent placement success
Time Frame: Day 0
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Ability to deploy the UAS-RBS in satisfactory position across the stricture
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Day 0
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Full deployment of stent
Time Frame: Day 0
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Endoscopic visualization
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Day 0
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Technical stent removal success
Time Frame: up to 6 months
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Ability to remove the stent without complications
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SAE during the period after stent removal
Time Frame: 6 months post retrieval
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6 months post retrieval
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Number of re-interventions
Time Frame: within 12 months following stent placement
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within 12 months following stent placement
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Change of dysphagia score (Dakkak and Bennett score of Dysphagia)
Time Frame: Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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Baseline and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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Patient's satisfaction with the therapy
Time Frame: week 1, month 1, 2, 3, 6, 9, 12 after implantation
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scored by a visual analog scale (0 worse - 10 best)
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week 1, month 1, 2, 3, 6, 9, 12 after implantation
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Patient's report of pain
Time Frame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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scored by a visual analog scale (0 worse - 10 best)
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before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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Quality Of Life SF36 questionnaire
Time Frame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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SF36
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before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2017/543
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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