Hernia, VentralNCT03074474
Ventral Hernia Study Using OviTex Reinforced Bioscaffold
A study testing OviTex 1S Permanent in people with Hernia, Ventral, run by Tela Bio Inc at 7 sites in United States.
Trial summary
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- OviTex 1S Permanent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Apr 2017to 8 Aug 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue.
- The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
- Subject is able to complete Quality of Life (QoL) and pain Questionnaires.
- Subject is at least 18 years old (or considered an adult per state law).
- Subject is able to participate fully in, and for the full duration of, the study.
Who cannot join
- Subject has a BMI of > 40.
- Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria.
- Subject is female and is pregnant.
- Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
- Subject has an allergy to ovine-derived products.
Show all 11Show fewer
- Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
- Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery.
- Intra-operative Exclusion Criteria
- Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm.
- Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of surgery.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Scripps Clinic
La Jolla, California, 92037
Comanche County Memorial Hospital
Lawton, Oklahoma, 73505
St. Luke's Hospital South
Overland Park, Kansas, 66213
St. Francis Hosptial
Roslyn, New York, 11576
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Capital Health
Trenton, New Jersey, 08638
About this study
Official title: A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.
Read the detailed description
The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed.
The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specific questionnaire and the same health assessment questionnaire as was done at the Baseline visit, however the subject will also be asked to complete a pain assessment. Both the surgeon and the subject will provide an assessment of his/her satisfaction with the hernia repair. The activities at Months 12 and 24 mirror those of Days 30 and 90, however the visit window is extended to +/- 4 weeks.
- Conditions
- Hernia, Ventral
- Being tested
- OviTex 1S Permanent
- Keywords
- use of 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.
OviTex 1S PermanentDevice
OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).
| Study group | Role | What they receive |
|---|---|---|
| OviTex Permanent 1S | Other | All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. Receives: Device: OviTex 1S Permanent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Occurrences or Wound-related Events
The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications <90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.
Measured: within the first three months of the ventral hernia repair
Secondary outcomes (4)
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery
Secondary outcome measures include the number of participants experiencing a hernia recurrence, post-operative SSO, wound related event at the hernia repair site, and other complications occurring at time points > 90 days after index surgery.
Measured: Overall Cumulative SSOs and Complications (0 - 24 Months)
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point
Hernia-Related Quality-of-Life Survey (HerQLes) assesses abdominal wall function and impact of ventral hernia repair on quality of life through 12 questions. Responses are graded on a likert scale from 1 to 6, 1=strongly disagree, 2=moderately disagree, 3=slightly disagree, 4=slightly agree, 5=moderately agree, 6=strongly agree. A raw score is calculated by the following formula:
12 question average = (Response to Q1 + Response to Q2 +…+ Response to Q12) / 12
A summary score is calculated by the following formula:
HerQLes Summary Score = 120-20*(12 Question Average) HerQLes scores range from 0 (worst possible response) to 100 (best possible response).
Data is reported as change in HerQLes Summary Score from baseline to each time point The scale was first reported in Krpata, D. M. et al. Design and Initial Implementation of HerQLes: A Hernia-Related Quality-of-Life Survey to Assess Abdominal Wall Function. J Am Coll Surgeons 215, 635-642 (2012).
Measured: Baseline through 24 months
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point
EuroQol 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) is a standardized generic (disease non-specific) quality of life scale measuring how good or bad the patients' health is on their visit date. The patient indicates on the scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine) how their health is with an X and reports the number in a box.
Data is reported as change in EQ-5D VAS score from baseline to each time point.
Measured: Baseline through 24 Months
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point
EuroQol 5 Dimensions (EQ-5D) is a standardized generic (disease non-specific) quality of life instrument measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are coded from 1 to 5 (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). The levels reported for each dimension create a 5-digit number (i.e. 11111 or 12345) based on patient response. These 5-digit numbers are converted to an index score by special algorithm that is not publicly available. The index value represents the patient's health status, where higher numbers are associated with better outcomes. Data is reported as change in EQ-5D Index value from baseline to each time point.
Measured: Baseline through 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start24 Apr 2017
- Primary completion8 Dec 2019
- Study completion8 Aug 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tela Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George DeNoto, MD, Principal investigator, Saint Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074474
- Sponsor's protocol ID
- TB2016.01.01
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2017
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex(R) 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022 Sep 27;83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov.
PubMed 36389188DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex(R) 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.
PubMed 34768516
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.
- ClinicalTrials.gov ID
- NCT03074474
- Acronym / sponsor ID
- TB2016.01.01
- Conditions
- Hernia, Ventral
- Keywords
- use of mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tela Bio IncIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 8 Aug 2021 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.
Detailed description
The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed.
The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specific questionnaire and the same health assessment questionnaire as was done at the Baseline visit, however the subject will also be asked to complete a pain assessment. Both the surgeon and the subject will provide an assessment of his/her satisfaction with the hernia repair. The activities at Months 12 and 24 mirror those of Days 30 and 90, however the visit window is extended to +/- 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OviTex Permanent 1S | Other | Device: OviTex 1S PermanentAll subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue.
- The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
- Subject is able to complete Quality of Life (QoL) and pain Questionnaires.
Key exclusion criteria (11 listed)
- Subject has a BMI of > 40.
- Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria.
- Subject is female and is pregnant.
- Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
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 |
|---|---|---|
| OviTex 1S PermanentOviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions). | Device | OviTex Permanent 1S |
Primary outcome
Surgical Site Occurrences or Wound-related Events
Time frame: within the first three months of the ventral hernia repair
The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications <90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.
4 secondary outcomes
Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery
Time frame: Overall Cumulative SSOs and Complications (0 - 24 Months)
Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point
Time frame: Baseline through 24 months
Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point
Time frame: Baseline through 24 Months
Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point
Time frame: Baseline through 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36389188DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex(R) 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022 Sep 27;83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov.
- Derived from this study: PubMed 34768516DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex(R) 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.
- Individual participant dataSharing planned: Undecided
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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.
George DeNoto, MD principal investigator
Saint Francis Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OviTex 1S Permanent in people with Hernia, Ventral, run by Tela Bio Inc at 7 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 7 inclusion and 11 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). 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?
Surgical Site Occurrences or Wound-related Events (time frame: within the first three months of the ventral hernia repair). 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 NCT03074474, which also lists 2 linked publications.
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 13 Jun 2023.