BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study (BIDARCA)

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

Study Overview

• Status: Unknown
• Conditions: Benign Esophageal Stricture
• Intervention / Treatment: Device: BD-Covered esophageal stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bram Vermeulen, Drs.; Phone Number: +31 0611079557; Email: bram.vermeulen@radboudumc.nl
• Study Contact Backup: Name: Peter Siersema, Dr.; Phone Number: +31 06 547 84 967; Email: peter.siersema@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BD-Covered stent; Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae	Device: BD-Covered esophageal stent; a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal pain, measured with VAS during follow-up after stent placement	Pain will be measured with the VAS during follow-up	6 months
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up	Recurrent dysphagia during follow-up	6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ELLA-CS , sro

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: NL.59222.091.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No