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HemorrhoidsPhase 1HEM-AVERTNCT00487045

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

A Phase 1 study testing Hem-Avert Perianal Stabilizer in people with Hemorrhoids, run by Stetrix, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Hemorrhoids
What is being tested?
Hem-Avert Perianal Stabilizer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
3 sitesUnited States
Study dates
Dec 2007to Jun 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Baptist Memorial Hospital-Tipton

    Covington, Tennessee, 38019

  • Baptist Women's Hospital

    Memphis, Tennessee, 38120

  • Baptist Memorial Hospital-Desoto

    Southaven, Mississippi, 38671

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Hemorrhoids
Being tested
Hem-Avert Perianal Stabilizer
Keywords
Hemorrhoids, Thrombosed External Hemorrhoids (TEH), Reduction, Prevention, Stabilizer Device, Pregnant, Vaginal Birth, Single Birth, Asymptomatic Hemorrhoids
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hem-Avert Perianal StabilizerDevice

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

Study groups in NCT00487045
Study groupRoleWhat they receive
1ExperimentalHem-Avert Perianal Stabilizer, single use, disposable, sterile, individually packaged instrument
Receives: Device: Hem-Avert Perianal Stabilizer
2No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Screening(Baseline), Delivery , Follow-up at Discharge (Total = 3 to 4 months)

Secondary outcomes (1)

  1. 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.

    Measured: Screening(Baseline), Delivery, Follow-up at Discharge (Total = 3 to 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00487045
Sponsor's protocol ID
PB_001
Acronym
HEM-AVERT
Status last verified
Jul 2009
First submitted
13 Jun 2007
Last updated
24 Jul 2009
Results posted
No
Data monitoring committee
Yes

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hem-Avert Perianal Stabilizer in people with Hemorrhoids, run by Stetrix, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00487045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2009.

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