Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids Using the HEM-AVERT Perianal Stabilizer Instrument (HEM-AVERT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00487045 |
Recruitment Status :
Completed
First Posted : June 15, 2007
Last Update Posted : July 24, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhoids | Device: Hem-Avert Perianal Stabilizer | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 176 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids (TEH) Using the HEM-AVERT Perianal Stabilizer Instrument |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Hem-Avert Perianal Stabilizer, single use, disposable, sterile, individually packaged instrument
|
Device: Hem-Avert Perianal Stabilizer
Hem-Avert Perianal Stabilizer, TNP-01L, single-use, disposable, sterile, individually packaged instrument |
No Intervention: 2 |
- Evaluate the success rate and assess the safety and efficacy of the HEM-AVERT™ instrument as a method of reducing the occurrence and/or severity of hemorrhoids and/or Thrombosed External Hemorrhoids (TEH), which commonly occur during vaginal delivery. [ Time Frame: Screening(Baseline), Delivery , Follow-up at Discharge (Total = 3 to 4 months) ]
- Grade presence or absence, # present, % of circumference of anus involved and volume of burden of hemorrhoids before & after delivery in both groups. Compare the occurrence of lacerations, anal fissures, and C-Sections in both groups. [ Time Frame: Screening(Baseline), Delivery, Follow-up at Discharge (Total = 3 to 4 months) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487045
United States, Mississippi | |
Baptist Memorial Hospital-Desoto | |
Southaven, Mississippi, United States, 38671 | |
United States, Tennessee | |
Baptist Memorial Hospital-Tipton | |
Covington, Tennessee, United States, 38019 | |
Baptist Women's Hospital | |
Memphis, Tennessee, United States, 38120 |
Principal Investigator: | J. Bradley Stern, M.D. | Baptist Memorial Health Care Corporation |
Responsible Party: | David Blurton, CEO of Plexus Biomedical, Inc. |
ClinicalTrials.gov Identifier: | NCT00487045 |
Other Study ID Numbers: |
PB_001 |
First Posted: | June 15, 2007 Key Record Dates |
Last Update Posted: | July 24, 2009 |
Last Verified: | July 2009 |
Hemorrhoids Thrombosed External Hemorrhoids (TEH) Reduction Prevention Stabilizer Device |
Pregnant Vaginal Birth Single Birth Asymptomatic Hemorrhoids |
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Vascular Diseases Cardiovascular Diseases |