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Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents

NCT ID: NCT00968552

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Diseases

Keywords

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Any Gastrointestinal problem that would require an endoscopically placed stent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing stent placement

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

Self-expandable stent placement via endoscopy

Intervention Type PROCEDURE

Self-expandable stent placement via endoscopy

Interventions

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Self-expandable stent placement via endoscopy

Self-expandable stent placement via endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shands UF endoscopy Center

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27612924 (View on PubMed)

Other Identifiers

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Stents/ERCP

Identifier Type: -

Identifier Source: org_study_id