External HemorrhoidNCT03479489
Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy
A study testing Human dehydrated amnion chorion allograft in people with External Hemorrhoid and External Hemorrhoid Thrombosed, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- External Hemorrhoid, External Hemorrhoid Thrombosed
- What is being tested?
- Human dehydrated amnion chorion allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 30 Dec 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of acutely thrombosed hemorrhoid or an external hemorrhoid exceeding 72 hours in duration
- Subject is undergoing closed hemorrhoidectomy as their definitive treatment for the Grade 2-4 hemorrhoid
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Who cannot join
- Subject has a known history of poor compliance with medical treatments
- Subject has signs and symptoms of active cirrhosis
- Subject has signs and symptoms of Crohn's disease complicated by perianal manifestations
- Subject is currently taking immunosuppressive medications
- Subject has had previous surgery in the target area within the past 6 months prior to treatment or plans to have surgery other than closed hemorrhoidectomy in the target area within 180 days of treatment
- Subject is currently receiving radiation therapy or chemotherapy
Show all 10Show fewer
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- Subject is pregnant at enrollment or is planning to become pregnant within 180 days of treatment; subject intends to breastfeed during the course of the trial
- Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject has an allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Valley Surgical Associates
Boulder, Colorado, 80303
About this study
Official title: A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane
The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.
- Being tested
- Human dehydrated amnion chorion allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human dehydrated amnion chorion allograftOther
Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
| Study group | Role | What they receive |
|---|---|---|
| Human dehydrated amnion/chorion allofraft | Experimental | Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft Receives: Other: Human dehydrated amnion chorion allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Patient Pain
The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions
- Do you experience pain continuously?
- Do you experience pain with activity?
- Do you experience pain while sitting?
- Do you experience pain with bowel movements?
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start5 Feb 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Fetterolf, MD, Study director, MiMedx Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479489
- Sponsor's protocol ID
- EFSUR001
- Status last verified
- Dec 2019
- First submitted
- 20 Mar 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series for Closed Hemorrhoidectomy - Efficacy of External Hemorrhoid Repair Using a Dehydrated Human Amnion Chorion Membrane
- ClinicalTrials.gov ID
- NCT03479489
- Acronym / sponsor ID
- EFSUR001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human dehydrated amnion/chorion allofraft | Experimental | Other: Human dehydrated amnion chorion allograftClosed hemorrhoidectomy patched with human dehydrated amnion chorion allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of acutely thrombosed hemorrhoid or an external hemorrhoid exceeding 72 hours in duration
- Subject is undergoing closed hemorrhoidectomy as their definitive treatment for the Grade 2-4 hemorrhoid
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Key exclusion criteria (10 listed)
- Subject has a known history of poor compliance with medical treatments
- Subject has signs and symptoms of active cirrhosis
- Subject has signs and symptoms of Crohn's disease complicated by perianal manifestations
- Subject is currently taking immunosuppressive medications
- Subject has had previous surgery in the target area within the past 6 months prior to treatment or plans to have surgery other than closed hemorrhoidectomy in the target area within 180 days of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human dehydrated amnion chorion allograftClosed hemorrhoidectomy patched with dehydrated human amnion chorion allograft | Other | Human dehydrated amnion/chorion allofraft |
Primary outcome
Reported Patient Pain
Time frame: 60 days
The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions * Do you experience pain continuously? * Do you experience pain with activity? * Do you experience pain while sitting? * Do you experience pain with bowel movements?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Fetterolf, MD study director
MiMedx Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human dehydrated amnion chorion allograft in people with External Hemorrhoid and External Hemorrhoid Thrombosed, run by MiMedx Group, Inc. at 1 site 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 4 inclusion and 10 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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Reported Patient Pain (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2019.