Back to resultsBD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study (BIDARCA)
Primary Purpose
Benign Esophageal Stricture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BD-Covered esophageal stent
Sponsored by
About this trial
This is an interventional treatment trial for Benign Esophageal Stricture
Eligibility Criteria
Inclusion Criteria:
- Subjects of both genders
- Age ≥ 18 years
- Appropriate cultural level and understanding of the study
- Willingness to participate voluntarily in the study and give written informed consent
- Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
- Ability to undergo periodic endoscopic follow-up.
Exclusion Criteria:
- Pregnancy or breastfeeding
- Simultaneous participation in another clinical study
- Life expectancy of less than 12 months
- Malignant esophageal stricture
- Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- Undergone an esophageal stent implantation before.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BD-Covered stent
Arm Description
Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae
Outcomes
Primary Outcome Measures
Incidence of treatment associated adverse events during follow-up (safety)
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Secondary Outcome Measures
Esophageal pain, measured with VAS during follow-up after stent placement
Pain will be measured with the VAS during follow-up
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Recurrent dysphagia during follow-up
Full Information
NCT ID
NCT03189927
First Posted
May 29, 2017
Last Updated
June 15, 2017
Sponsor
Radboud University Medical Center
Collaborators
ELLA-CS , sro
1. Study Identification
Unique Protocol Identification Number
NCT03189927
Brief Title
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
Acronym
BIDARCA
Official Title
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ELLA-CS , sro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
Detailed Description
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Esophageal Stricture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BD-Covered stent
Arm Type
Experimental
Arm Description
Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae
Intervention Type
Device
Intervention Name(s)
BD-Covered esophageal stent
Intervention Description
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Primary Outcome Measure Information:
Title
Incidence of treatment associated adverse events during follow-up (safety)
Description
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
Time Frame
6 months
Title
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Description
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Esophageal pain, measured with VAS during follow-up after stent placement
Description
Pain will be measured with the VAS during follow-up
Time Frame
6 months
Title
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Description
Recurrent dysphagia during follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of both genders
Age ≥ 18 years
Appropriate cultural level and understanding of the study
Willingness to participate voluntarily in the study and give written informed consent
Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
Ability to undergo periodic endoscopic follow-up.
Exclusion Criteria:
Pregnancy or breastfeeding
Simultaneous participation in another clinical study
Life expectancy of less than 12 months
Malignant esophageal stricture
Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
Undergone an esophageal stent implantation before.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bram Vermeulen, Drs.
Phone
0611079557
Ext
+31
Email
bram.vermeulen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Peter SiersemA, Dr.
Phone
06 547 84 967
Ext
+31
Email
peter.siersema@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
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