NCT00968552

Brief Summary

The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

7.2 years

First QC Date

August 28, 2009

Last Update Submit

October 25, 2016

Conditions

Gastrointestinal Diseases

Keywords

Any Gastrointestinal problem that would require an endoscopically placed stent

Outcome Measures

Primary Outcomes (1)

  • The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.

    at the time of stent placement

Study Arms (1)

Patients undergoing stent placement

Patients who are scheduled to undergo stent placement via endoscopy as part of their routine medical care.

Procedure: Self-expandable stent placement via endoscopy

Interventions

Self-expandable stent placement via endoscopyPROCEDURE

Self-expandable stent placement via endoscopy

Patients undergoing stent placement

Eligibility Criteria

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

Age 18 or older

You may qualify if:

  • Age 18 years or older.
  • Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
  • Subject must be able to give informed consent.

You may not qualify if:

  • Any contraindication to performing endoscopy.
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  • The subject is unable/unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands UF endoscopy Center

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Wagh MS, Draganov PV. Per-oral endoscopic tunneling for restoration of the esophagus: a novel endoscopic submucosal dissection technique for therapy of complete esophageal obstruction. Gastrointest Endosc. 2017 Apr;85(4):722-727. doi: 10.1016/j.gie.2016.08.035. Epub 2016 Sep 7.

    PMID: 27612924DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

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

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)