NCT03269903

TTS Esophageal HILZO Stent: A Safety and Feasibility Study

TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 malignant dysphagia

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 the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DEVICE	HILZO esophageal stent	A fully covered esophageal self-expandable metal stent for malignant dysphagia

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-03-01
• Completion: 2018-09-01
• First posted: 2017-09-01
• Last updated: 2017-09-01

Locations

1 site across 1 country: Netherlands