NCT01301495

Brief Summary

In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

February 17, 2011

Last Update Submit

June 1, 2015

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer

Outcome Measures

Primary Outcomes (1)

  • Palliation assessment based on Dysphagia Scores

    To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;

    2 years

Secondary Outcomes (1)

  • Assessment of Complications and MD Anderson Dysphagia Score

    2-4 years

Study Arms (1)

HANAROSTENT covered Esophageal Stent

EXPERIMENTAL
Device: HANAROSTENT TM covered Esophageal Stent

Interventions

HANAROSTENT TM covered Esophageal StentDEVICE

HANAROSTENT covered Esophageal Stent for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula

Also known as: HANAROSTENT
HANAROSTENT covered Esophageal Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inoperable malignant obstruction of the esophageal or gastric cardia
  • Malignant fistula between the esophagus ans respiratory tree
  • Recurrent cancer after prior radiation

You may not qualify if:

  • Patient unstable for endoscopic procedure
  • Previous esophageal stenting
  • Tumor growth within 2 cm of the upper esophageal sphincter
  • Pregnant women (self reported, no pregnancy test will be done per protocol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsDeglutition DisordersNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Michel Kahaleh, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Advanced Endoscopy

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 23, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

US(1)