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TVT-SECUR as an Office-based Procedure

NCT01137539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-06-28

Study results available
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Summary

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.

Conditions

Interventions

DEVICE

Gynecare TVT-SECUR system

All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • Michigan Institution of Women's Health PC

    lead OTHER

Principal Investigators

  • Salil S Khandwala, MD · Michigan Institute of Women's Health PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137539 on ClinicalTrials.gov