Transvaginal NOTES Sleeve Gastrectomy

NCT ID: NCT01402505

Last Updated: 2020-03-31

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2018-10-31

Brief Summary

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This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transvaginal NOTES sleeve gastrectomy

Transvaginal NOTES sleeve gastrectomy

Transvaginal NOTES sleeve gastrectomy

Intervention Type PROCEDURE

transvaginal NOTES sleeve gastrectomy

Interventions

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Transvaginal NOTES sleeve gastrectomy

transvaginal NOTES sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of morbid obesity BMI \> 40
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

Exclusion:

1. Pregnant women
2. BMI \< 40
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Santiago Horgan

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Santiago Horgan, M.D., FACS

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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081036, 141812

Identifier Type: -

Identifier Source: org_study_id

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