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

Completed · Phase 1

Conditions studied: Hemorrhoids

In brief

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.

Key facts

Study ID

NCT00487045

Run by

Stetrix, Inc.

People needed

176

Starts

2007-12-01

Expected to finish

2009-06-01

Last updated by the study team

2009-07-24

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18 and 40 years of age, female and pregnant.
• Subject weighs 130 pounds or greater at time of delivery.
• Subject is scheduled for vaginal delivery.
• Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
• Subject's pre-natal examination indicates that this is to be a single birth delivery.
• Subject has no current hemorrhoids or has low grade hemorrhoids.
• Subject's with previous history of hemorrhoids that are visually asymptomatic at time of screening (history) and physical examination are also acceptable
• Subject has no lacerations or anal fissures
• Subject is not a prisoner

You may not qualify if…

• Subject is younger than 18 years of age or older than 40 years of age.
• Subject weighs less than 130 pounds at time of delivery.
• Subject has hemorrhoids other than low grade
• Subject has had previous rectal surgery (e.g., hemorrhoidectomy)
• Subject has lacerations or anal fissures
• Subject has a documented allergy to the instrument's materials.
• Subject's scheduled for vaginal delivery with anticipated complications [such as breech presentation]
• Subject is unable to understand and sign the informed consent form.
• Subject is a prisoner.

Where it is running

• Baptist Memorial Hospital-Desoto — Southaven, Mississippi, United States
• Baptist Memorial Hospital-Tipton — Covington, Tennessee, United States
• Baptist Women's Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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