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Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids Using the HEM-AVERT Perianal Stabilizer Instrument

NCT00487045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2009-07-24

No results posted yet for this study

Summary

This study is being conducted to evaluate an investigational instrument called the HEM-AVERT Perianal Stabilizer and its efficacy in reducing the occurrence or severity of hemorrhoids and thrombosed external hemorrhoids (TEH) which commonly occur during vaginal delivery.

Conditions

Interventions

DEVICE

Hem-Avert Perianal Stabilizer

Hem-Avert Perianal Stabilizer, TNP-01L, single-use, disposable, sterile, individually packaged instrument

Sponsors & Collaborators

  • Baptist Memorial Health Care Corporation

    collaborator OTHER

  • Stetrix, Inc.

    lead INDUSTRY

Principal Investigators

  • J. Bradley Stern, M.D. · Baptist Memorial Health Care Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT00487045 on ClinicalTrials.gov