Inguinal HerniaPhase 4NCT00968773
Rebound Hernia Repair Device Mesh Trial
A Phase 4 study testing Rebound HRD and Standard hernia mesh (VitaMesh) in people with Inguinal Hernia, run by Minnesota Medical Development, Inc. at 2 sites in United States.
Trial summary
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Rebound HRD and Standard hernia mesh (VitaMesh)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Sep 2013
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age
- Unilateral or bilateral inguinal hernia (moderate in size), primary in nature
Who cannot join
- Unable to provide informed consent
- Assessed as ASA 3 or 4
- Renal failure;creatinine greater than 2.0mg percent
- Ascites as determined by clinical suspicion/ultrasound confirmation
- Known pregnancy
- Femoral hernias
Show all 13Show fewer
- Diabetes requiring injectable insulin
- Prior lower abdominal surgery through lower midline or Pfannenstiel incision
- TAPP approach
- Requiring anticoagulants during surgery
- Participation in another study involving another device or drug
- Emergent procedures for hernia incarceration and strangulation
- Recurrent inguinal hernias
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State Medical Center, Dept. of Surgery
Columbus, Ohio, 43210-1228
University of Kentucky Dept. Of Surgery
Lexington, Kentucky, 40536-0293
About this study
Official title: Rebound Hernia Repair Device Trial
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.
The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.
- Conditions
- Inguinal Hernia
- Being tested
- Rebound HRD, Standard hernia mesh (VitaMesh)
- Keywords
- inguinal hernia, mesh, hernia repair device
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebound HRDDevice
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
Standard hernia mesh (VitaMesh)Device
Also called VitaMesh
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation
| Study group | Role | What they receive |
|---|---|---|
| The Rebound hernia repair device with no fixation | Experimental | Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature. Receives: Device: Rebound HRD |
| Standard Hernia Mesh using fixation | Active comparator | Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature. Receives: Device: Standard hernia mesh (VitaMesh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hernia recurrence
Measured: 2 years
Secondary outcomes (1)
Pain and discomfort to patients using VAS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minnesota Medical Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky, Ohio State University
- Investigators
- John S Roth, MD, Principal investigator, University of KentuckyJeffrey W Hazey, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968773
- Sponsor's protocol ID
- Rebound HRD
- Status last verified
- Sep 2009
- First submitted
- 27 Aug 2009
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Hernia Repair Device Trial
- ClinicalTrials.gov ID
- NCT00968773
- Acronym / sponsor ID
- Rebound HRD
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, mesh, hernia repair device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Minnesota Medical Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky, Ohio State University
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 31 Aug 2009 (estimated)
- 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.
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.
The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Rebound hernia repair device with no fixation | Experimental | Device: Rebound HRDCompetent adults who have a unilateral, bilateral inguinal hernia that is primary in nature. |
| Standard Hernia Mesh using fixation | Active comparator | Device: Standard hernia mesh (VitaMesh)Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 80 years of age
- Unilateral or bilateral inguinal hernia (moderate in size), primary in nature
Key exclusion criteria (13 listed)
- Unable to provide informed consent
- Assessed as ASA 3 or 4
- Renal failure;creatinine greater than 2.0mg percent
- Ascites as determined by clinical suspicion/ultrasound confirmation
- Known pregnancy
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 |
|---|---|---|
| Rebound HRDLaparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation | Device | The Rebound hernia repair device with no fixation |
| Standard hernia mesh (VitaMesh)Also: VitaMeshLaparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation | Device | Standard Hernia Mesh using fixation |
Primary outcome
Presence of hernia recurrence
Time frame: 2 years
1 secondary outcome
Pain and discomfort to patients using VAS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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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
Jeffrey W Hazey, MD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebound HRD and Standard hernia mesh (VitaMesh) in people with Inguinal Hernia, run by Minnesota Medical Development, Inc. at 2 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Presence of hernia recurrence (time frame: 2 years). 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 15 Mar 2016.