Status:
UNKNOWN
TTS Esophageal HILZO Stent: A Safety and Feasibility Study
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Kebomed B.V.
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of m...
Detailed Description
The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of th...
Eligibility Criteria
Inclusion
- Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease. OR
- Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
- Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2)
- Written informed consent
- Age ≥ 18 years
Exclusion
- Inappropriate cultural level and understanding of the study.
- Simultaneous participation in another clinical study
- Life expectancy of less than 12 months
- Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- Tumor length of more than 12cm
- Previous stent placement for the same condition
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03269903
Start Date
March 1 2017
End Date
September 1 2018
Last Update
September 1 2017
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB