Ventral Hernia Repair
Conditions
Brief 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.
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.
Interventions
DEVICESilk surgical mesh
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
Sponsors
Sofregen Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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: 1. Midline Ventral Hernia AND 2. Defect(s) MUST meet the following criteria: * contained within an anatomical area of ≤ 150 cm2 * not be longer than 8cm in any direction * size must have a total sum ≤ 64 cm2 3. Be eligible for retro-rectus placement of SERI 4. Have a BMI \< 40
Exclusion criteria
The following are criteria for exclusion from participating in the study. The subject must NOT: 1. Be \> 70 years of age 2. Have prior occurrence of ventral hernia or parastomal hernia 3. Have a presence of a stoma or have a perforated bowel 4. 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 5. Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hernia Recurrence | 6 months postoperatively | Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SERI® Surgical Scaffold It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.
Silk surgical mesh: 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | SERI® Surgical Scaffold |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Rate of Hernia Recurrence
Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 6 months postoperatively
Population: Adults between 18 and 70 years of age with SERI for ventral hernia repair
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Intact primary hernia repair with SERI | 1 Participants |
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Hernia reoccurred | 0 Participants |
Primary
Rate of Hernia Recurrence
Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 12 months postoperatively
Population: Adults between 18 and 70 years of age using SERI for ventral hernia repair
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Intact primary hernia repair | 1 Participants |
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Hernia reoccurred | 0 Participants |
Primary
Rate of Hernia Recurrence
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 24 months postoperatively
Population: Adults between 18 and 70 years of age with SERI for ventral hernia repair
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Intact primary repair with SERI | 1 Participants |
| SERI® Surgical Scaffold | Rate of Hernia Recurrence | Hernia reoccurrence | 0 Participants |