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

NCT03189927 | Unknown DMC

• 1 other identifier: NL.59222.091.16
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

Benign Esophageal Stricture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Esophageal pain, measured with VAS during follow-up after stent placement

  6 months

• Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up

  6 months

Study Arms (1)

BD-Covered stent

EXPERIMENTAL

Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae

Device: BD-Covered esophageal stent

Interventions

BD-Covered esophageal stent DEVICE

a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures

BD-Covered stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ELLA-CS , sro: collaborator

Central Study Contacts

Bram Vermeulen, Drs.

CONTACT

0611079557; bram.vermeulen@radboudumc.nl

Peter SiersemA, Dr.

CONTACT

06 547 84 967; peter.siersema@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 16, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share