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

NCT ID: NCT01981044

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-25
• Study Completion Date: 2016-02-24

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.

Conditions

Ventral Hernia Repair

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SERI® Surgical Scaffold

It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.

Group Type: EXPERIMENTAL

Silk surgical mesh

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

SERI® Surgical Scaffold

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sofregen Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan Medical

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Related Links

http://www.allerganclinicaltrials.com

More Information

Other Identifiers

SURE-007

Identifier Type: -

Identifier Source: org_study_id