A Fully Covered Irradiation Stent for the Palliation of Malignant Dysphagia

NCT03186014 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-06-14

No results posted yet for this study

Summary

Dysphagia is the major symptom of patients with malignant esophageal stricture caused predominantly by advanced esophageal cancer. Stent placement is the most commonly used strategies for relieving the dysphagia and a novel irradiation stent loaded with 125I seeds has recently been developed. A multicentre randomized clinical trial demonstrated this irradiation stent can relieve the dysphagia rapidly and prolong the survival of patients with advanced esophageal cancer, but the total stent stenosis rate cannot be ruduced. A novel fully covered segmented retrievable irradiation stent was developed in our institute. The purpose of this study is to evaluate the safety and clinical efficacy of this newly developed irradiation stent in patients with unresectable malignant dysphagia.

Conditions

  • Malignant Dysphagia

Interventions

DEVICE

Fully covered irradiation stent

A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Gao-jun Teng, Ph.D,MD · Zhongda Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186014 on ClinicalTrials.gov