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

July 23, 2009 updated by: Stetrix, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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). Hemorrhoids and TEH are caused by blood pooling in a distended vein and forming a clot, or thrombose, in the outer region of the anus. An anal fissure is a small split or tear in the anal mucosa that may result in painful bowel movements and bleeding. Like hemorrhoids, anal fissures are common in women after childbirth. Lacerations are graded as first, second, third and fourth degree. First and second degree are perineal lacerations and involve the mucosa and perineum and usually heal by themselves. First and second degree lacerations are considered to be a normal occurrence in child birth. Third degree lacerations involve the anal sphincter and fourth degree lacerations involve the sphincter and mucosa of the anus with bowel involvement and usually require surgical repair. Per the product classification that was assigned to this instrument by the FDA, the instrument is both non-invasive and posses a non-significant risk. It is classified as a manual, general instrument with no specific indications, but has a general indication of stabilizing pressure. The purpose of this clinical study is to collect data to support a 510(k) application to obtain the specific indication of preventing the occurrence of hemorrhoids, or reducing the severity of hemorrhoids which often occur during vaginal deliveries. Hemorrhoids and TEH represent common adverse events in vaginal births with reported occurrences ranging from a low of 9% to a high of 34% in the reported literature. Currently no preventative treatment exists. There will be two study groups; an investigational group (subjects receiving the HEM-AVERT™ instrument) and the control group (subjects will not receive the HEM-AVERT™ instrument). The HEM-AVERT™ Perianal Stabilizer is a Class 1, exempt device in accordance with FDA regulation 21 CFR 890.5765. The HEM-AVERT™ is a non-invasive instrument used to provide continuous pressure to the perianal region as a means to help provide support during the labor process. Each HEM-AVERT™ instrument is a single use, disposable, sterile, individually packaged instrument. The HEM-AVERT™ instrument consists of three components: 1) a rigid polymer base manufactured from a medical grade polycarbonate; 2) a centrally located cushioning pad which is composed of a laminate of medical grade polyester non-woven tape and medical grade polyethylene foam tape; and 3) two lateral hook and loop fastener adhesive strips (with liners) ("loop" strips that attach to the mating "hook" [similar to VELCRO®]) which is used to provide the tension needed to keep the instrument firmly in place during delivery. The cushioning pad and adhesive strips are manufactured using materials commonly found in medical instruments and used in medical procedures. All of the materials used to manufacture this instrument meet the available national or international standards specifications as applied to this instrument. This instrument is not to be implanted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital-DeSoto
    • Tennessee
      • Covington, Tennessee, United States, 38019
        • Baptist Memorial Hospital-Tipton
      • Memphis, Tennessee, United States, 38120
        • Baptist Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 2
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Screening(Baseline), Delivery , Follow-up at Discharge (Total = 3 to 4 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Screening(Baseline), Delivery, Follow-up at Discharge (Total = 3 to 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stetrix, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baptist Memorial Health Care Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: J. Bradley Stern, M.D., Baptist Memorial Health Care Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Abramowitz L. et.al. Epidemiology of anal fissures (fissure and thrombosed external hemorrhoid) during pregnancy and post-partum. Gynecxologie Obstetrique Fertilite, 31:546-549, 2003. Abramowitz L. et.al. Anal fissures and thrombosed external hemorrhoids before and after delivery. Dis. Colon Rectum, 45:650-655, 2002. Brown S, Luley J. Maternal health after childbirth: Results of an australian population based survey. British Journal Obstet Gynaecol. 105(2):156-161, 1998. Byrd LM, Hobbiss J, Tasker M. Is it possible to predict or prevent third degree tears? Colorectal Disease. 7(4):311-318, 2005. Gjerdingen DK, Froberg DG, Chaloner KM, McGovern, PM. Changes in women's physical health during first postpartum year. Arch Fam Med. 2:277-283, 1993. Cohen J. Statistical power analysis for the behavioral sciences. Second Edition. Hillsdale NJ: Lawrence Erlbaum Associates,Inc. 1988.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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