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

Benign Esophageal Stricture Clinical Trial

— BIDARCA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03189927
• Other study ID #: NL.59222.091.16
• Status: Not yet recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: June 15, 2017
• Start date: July 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2017
• Source: Radboud University
• Contact: Bram Vermeulen, Drs.
• Phone: 0611079557
• Email: bram.vermeulen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Esophageal Stricture
• Constriction, Pathologic
• Esophageal Stenosis

Intervention

Device:
• BD-Covered esophageal stent
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ELLA-CS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Esophageal pain, measured with VAS during follow-up after stent placement	Pain will be measured with the VAS during follow-up	6 months
Secondary	Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up	Recurrent dysphagia during follow-up	6 months