Ventral Hernia RepairNCT01981044
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
A study testing Silk surgical mesh in people with Ventral Hernia Repair, run by Sofregen Medical, Inc. at 1 site in United States.
Trial summary
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- Silk surgical mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2013to 24 Feb 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following are requirements for entry into the study. The subject MUST:
- 1. Be ≥ 18 years of age
- 2. Be diagnosed with a ventral hernia as defined as:
- Midline Ventral Hernia AND
- Defect(s) MUST meet the following criteria:
- contained within an anatomical area of ≤ 150 cm2
Show all 10Show fewer
- not be longer than 8cm in any direction
- size must have a total sum ≤ 64 cm2
- Be eligible for retro-rectus placement of SERI
- Have a BMI < 40
Who cannot join
- The following are criteria for exclusion from participating in the study. The subject must
- NOT:
- Be > 70 years of age
- Have prior occurrence of ventral hernia or parastomal hernia
- Have a presence of a stoma or have a perforated bowel
- Have any documented disease which is clinically known to impact wound healing, including Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure (CHF), with the exception of controlled diabetes
Show all 26Show fewer
- Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit
- Have documented autoimmune disease, an immune deficiency, or be on immunosuppressive drugs with the exception of steroids for:
- 1. prophylactic one-time-use administered peri-operatively
- 2. inhaled general use
- 3. topical administration
- 7. Have documented collagen-vascular, connective tissue, bleeding disorders and/or on anticoagulation therapy, with the exception of baby aspirin for one week prior to SERI placement
- 8. Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months prior to surgery
- 9. Have documented history of abdominal radiation therapy or is expected to have abdominal radiation therapy during the conduct of this study
- 10. Have documented history of liver disease and/or renal failure requiring dialysis
- 11. Have documented history of a previous wound infection at the surgical site or have an active infection at the time of surgery
- 12. Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or pelvic area
- 13. Have documented allergy to silk
- 14. Have documented UTI at the time of surgery
- 15. Have smoked within 6 weeks of surgery and have a positive nicotine test at time of preoperative visit
- 16. Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal adhesions)
- 17. Require intra-peritoneal or bridging placement of the soft tissue support device or require component separation at time of surgery
- 18. Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold per the supplied package insert
- 19. Have a concomitant unrelated condition of abdominal/chest wall/skin that would require a surgical intervention during the follow-up period
- 20. Have documented alcohol and/or substance abuse problem at time of pre-operative visit
- 21. Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
Read the detailed description
Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects.
- Conditions
- Ventral Hernia Repair
- Being tested
- Silk surgical mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk surgical meshDevice
Also called SERI® Surgical Scaffold
A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
| Study group | Role | What they receive |
|---|---|---|
| SERI® Surgical Scaffold | Experimental | It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Receives: Device: Silk surgical mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hernia Recurrence
Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Measured: 6 months postoperatively
Rate of Hernia Recurrence
Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Measured: 12 months postoperatively
Rate of Hernia Recurrence
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Measured: 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study start25 Sep 2013
- Primary completion25 Sep 2015
- Study completion24 Feb 2016
Why it stopped: Difficulty accruing patients; business decision
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.
- Other trials for Ventral Hernia RepairStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofregen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981044
- Sponsor's protocol ID
- SURE-007
- Status last verified
- Aug 2022
- First submitted
- 24 Oct 2013
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01981044
- Acronym / sponsor ID
- SURE-007
- Conditions
- Ventral Hernia Repair
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing patients; business decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sofregen Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 25 Sep 2015 (actual)
- Study completion
- 24 Feb 2016 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 26 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
Detailed description
Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SERI® Surgical Scaffold | Experimental | Device: Silk surgical meshIt is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Be ≥ 18 years of age
- Midline Ventral Hernia AND
- Defect(s) MUST meet the following criteria:
- Be eligible for retro-rectus placement of SERI
- Have a BMI < 40
Key exclusion criteria (26 listed)
- The following are criteria for exclusion from participating in the study. The subject must
- Be > 70 years of age
- Have prior occurrence of ventral hernia or parastomal hernia
- Have a presence of a stoma or have a perforated bowel
- Have any documented disease which is clinically known to impact wound healing, including Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure (CHF), with the exception of controlled diabetes
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 |
|---|---|---|
| Silk surgical meshAlso: SERI® Surgical ScaffoldA CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair | Device | SERI® Surgical Scaffold |
Primary outcome
Rate of Hernia Recurrence
Time frame: 6 months postoperatively
Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Rate of Hernia Recurrence
Time frame: 12 months postoperatively
Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Rate of Hernia Recurrence
Time frame: 24 months postoperatively
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk surgical mesh in people with Ventral Hernia Repair, run by Sofregen Medical, 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 10 inclusion and 26 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: stopped early, as of the sponsor's last update on 26 Aug 2022. 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 26 Aug 2022). 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?
Rate of Hernia Recurrence (time frame: 6 months postoperatively). The study lists 3 primary outcomes in all. 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 26 Aug 2022.