Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids Using the HEM-AVERT Perianal Stabilizer Instrument
HEM-AVERT
1 other identifier
interventional
176
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 24, 2009
July 1, 2009
1.5 years
June 13, 2007
July 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the success rate and assess the safety and efficacy of the HEM-AVERTâ„¢ 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.
Screening(Baseline), Delivery , Follow-up at Discharge (Total = 3 to 4 months)
Secondary Outcomes (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.
Screening(Baseline), Delivery, Follow-up at Discharge (Total = 3 to 4 months)
Study Arms (2)
1
EXPERIMENTALHem-Avert Perianal Stabilizer, single use, disposable, sterile, individually packaged instrument
2
NO INTERVENTIONInterventions
Hem-Avert Perianal Stabilizer, TNP-01L, single-use, disposable, sterile, individually packaged instrument
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stetrix, Inc.lead
- Baptist Memorial Health Care Corporationcollaborator
Study Sites (3)
Baptist Memorial Hospital-Desoto
Southaven, Mississippi, 38671, United States
Baptist Memorial Hospital-Tipton
Covington, Tennessee, 38019, United States
Baptist Women's Hospital
Memphis, Tennessee, 38120, United States
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Bradley Stern, M.D.
Baptist Memorial Health Care Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 15, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 24, 2009
Record last verified: 2009-07