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

Ventral Hernia Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01981044
• Other study ID #: SURE-007
• Status: Terminated
• Phase: N/A
• Start date: September 25, 2013
• Est. completion date: February 24, 2016

Study information

• Verified date: August 2022
• Source: Sofregen Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 24, 2016
• Est. primary completion date: September 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia Repair

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Sofregen Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months postoperatively
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.	12 months postoperatively
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.	24 months postoperatively

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