Ventral HerniaNCT01863030
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
An observational study of Ventral Hernia, run by John Roth at 1 site in United States.
Trial summary
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Phasix mesh implant
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patents with ventral hernias that meet eligibility criteria.
Who may be able to join
- The subject must meet all of the relevant criteria listed below to be enrolled in the study:
- Subject must be ≥18 years of age.
- Subject or subject's legally authorized representative must be willing give written informed consent.
- Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
- Hernia size greater than 10cm2 and less than 250cm2
- Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Who cannot join
- The subject must be excluded from study enrollment if any of the following criteria are met:
- Subject's hernia is multiply recurrent.
- CDC wound classification other than clean or clean-contaminated
- The use of surgical repair as a bridge.
- Patient has a contraindication to placement of mesh.
- Concomitant procedures with wound classification other than clean
Show all 15Show fewer
- Subject has peritonitis.
- Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
- Subject's body mass index (BMI) >55 kg/m2.
- Subject has cirrhosis, and/or ascites.
- Subject is American Society of Anesthesiology Class 4 or 5.
- Subject is known to be infected with human immunodeficiency virus (HIV).
- Subject has known allergies to tetracycline or kanamycin.
- Subject has a life expectancy of less than 2 years at the time of enrollment.
- Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:
- Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
- Perioperative, short-term and long-term procedural and/or device related complications.
- Abdominal Wall Function and mobility.
- Conditions
- Ventral Hernia
- Being tested
- Phasix mesh implant
- Keywords
- Resorbable mesh, Phasix mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phasix mesh implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Phasix mesh | Mesh being used for approved use. Mesh for ventral and incisional hernias. Receives: Device: Phasix mesh implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
Measured: up to 24 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Roth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Roth, University of Kentucky
- Investigators
- John S Roth, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863030
- Sponsor's protocol ID
- Phasix
- Status last verified
- Jan 2020
- First submitted
- 14 May 2013
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15.
PubMed 28916979
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT01863030
- Acronym / sponsor ID
- Phasix
- Conditions
- Ventral Hernia
- Keywords
- Resorbable mesh, Phasix mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- John RothUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:
- Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
- Perioperative, short-term and long-term procedural and/or device related complications.
- Abdominal Wall Function and mobility.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phasix mesh | – | Device: Phasix mesh implantMesh being used for approved use. Mesh for ventral and incisional hernias. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patents with ventral hernias that meet eligibility criteria.
Key inclusion criteria (6 listed)
- The subject must meet all of the relevant criteria listed below to be enrolled in the study:
- Subject must be ≥18 years of age.
- Subject or subject's legally authorized representative must be willing give written informed consent.
- Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
- Hernia size greater than 10cm2 and less than 250cm2
Key exclusion criteria (15 listed)
- The subject must be excluded from study enrollment if any of the following criteria are met:
- Subject's hernia is multiply recurrent.
- CDC wound classification other than clean or clean-contaminated
- The use of surgical repair as a bridge.
- Patient has a contraindication to placement of mesh.
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 |
|---|---|---|
| Phasix mesh implant | Device | Phasix mesh |
Primary outcome
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Time frame: up to 24 months post surgery
Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28916979Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15.
- Individual participant dataSharing planned: No
Related trials for Ventral Hernia
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
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.
John S Roth, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by John Roth 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 6 inclusion and 15 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 21 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh (time frame: up to 24 months post surgery). 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 NCT01863030, 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 21 Jan 2020.