Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

NCT00737061 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2017-09-08

Study results available
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Summary

The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.

Conditions

  • Reproductive Sterilization

Interventions

DEVICE

Adiana Transcervical Sterilization System

Implantation of silicone matrix in fallopian tubes

Sponsors & Collaborators

  • QST Consultations, Ltd.

    collaborator INDUSTRY
  • Hologic, Inc.

    lead INDUSTRY

Principal Investigators

  • Edward Evantash, MD · Hologic, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2005-12-31
Completion
2013-02-04

Countries

  • United States
  • Australia
  • Mexico

Study Locations

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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 NCT00737061 on ClinicalTrials.gov