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UAS-RBS: a Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652285
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Refractory Benign Strictures Device: Esophageal stent implantation Device: Stent removal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

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
Device: Esophageal stent implantation

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.


Device: Stent removal
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.




Primary Outcome Measures :
  1. Incidence of all Adverse Device Effects [ Time Frame: 6 months ]
    Serious adverse event (SAE) during the period of stent implantation

  2. Technical stent placement success [ Time Frame: Day 0 ]
    Ability to deploy the UAS-RBS in satisfactory position across the stricture

  3. Full deployment of stent [ Time Frame: Day 0 ]
    Endoscopic visualization

  4. Technical stent removal success [ Time Frame: up to 6 months ]
    Ability to remove the stent without complications


Secondary Outcome Measures :
  1. SAE during the period after stent removal [ Time Frame: 6 months post retrieval ]
  2. Number of re-interventions [ Time Frame: within 12 months following stent placement ]
  3. 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 ]
  4. Patient's satisfaction with the therapy [ Time Frame: week 1, month 1, 2, 3, 6, 9, 12 after implantation ]
    scored by a visual analog scale (0 worse - 10 best)

  5. Patient's report of pain [ Time Frame: 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)

  6. Quality Of Life SF36 questionnaire [ Time Frame: before treatment, and at week 1, month 1, 2, 3, 6, 9, 12 after implantation ]
    SF36



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652285


Locations
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Belgium
CUB Hopital erasme Recruiting
Anderlecht, Belgium, 1070
Contact: Jacques Deviere, MD, PhD    3225553715    Jacques.Deviere@erasme.ulb.ac.be   
Contact: Vincent Huberty, MD    3225553715    vincent.huberty@erasme.ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03652285    
Other Study ID Numbers: P2017/543
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical