NCT01238913

Brief Summary

The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
4.8 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

November 5, 2010

Last Update Submit

September 29, 2015

Conditions

Benign Esophageal Lesions

Outcome Measures

Primary Outcomes (1)

  • Successful stenting of Benign esophageal lesions

    This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.

    approximately 2-3 hours

Study Arms (1)

benign esophageal lesions

All patients who have a benign esophageal lesion where it is medically indicated that they receive a stent.

Procedure: Endoscopy

Interventions

EndoscopyPROCEDURE

Endoscopic placement of an esophageal metal stent as per medical indication.

benign esophageal lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have a medical indication for endoscopic placement of esophageal metal stent and are referred for the porcedure as part of their standard medical care will be considered for the study.

You may qualify if:

  • Subject is 18 years or older
  • Subject has medical indication to undergo endoscopic placement of esophageal metal stent
  • Subject must be able to give informed consent

You may not qualify if:

  • Any contraindications for endoscopic placement of esophageal metal stent
  • The subject is unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Peter Draganov, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 11, 2010

Study Start

September 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09