SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Sofregen Medical

Status

Terminated

Conditions

Ventral Hernia Repair

Treatments

Device: Silk surgical mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981044

SURE-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The following are requirements for entry into the study. The subject MUST:

Be ≥ 18 years of age
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
- 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

Exclusion criteria

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
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:
prophylactic one-time-use administered peri-operatively
inhaled general use
topical administration
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
Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months prior to surgery
Have documented history of abdominal radiation therapy or is expected to have abdominal radiation therapy during the conduct of this study
Have documented history of liver disease and/or renal failure requiring dialysis
Have documented history of a previous wound infection at the surgical site or have an active infection at the time of surgery
Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or pelvic area
Have documented allergy to silk
Have documented UTI at the time of surgery
Have smoked within 6 weeks of surgery and have a positive nicotine test at time of preoperative visit
Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal adhesions)
Require intra-peritoneal or bridging placement of the soft tissue support device or require component separation at time of surgery
Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold per the supplied package insert
Have a concomitant unrelated condition of abdominal/chest wall/skin that would require a surgical intervention during the follow-up period
Have documented alcohol and/or substance abuse problem at time of pre-operative visit
Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study