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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01981044
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Ventral Hernia Repair Device: Silk surgical mesh

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2013
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SERI® Surgical Scaffold
It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.
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
Other Name: SERI® Surgical Scaffold


Outcome Measures

Primary Outcome Measures :
  1. Rate of hernia recurrence [ Time Frame: 24 months postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981044


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Sofregen Medical, Inc.
Investigators
Study Director: Medical Director Allergan Medical
More Information

Additional Information:
Responsible Party: Sofregen Medical, Inc.
ClinicalTrials.gov Identifier: NCT01981044     History of Changes
Other Study ID Numbers: SURE-007
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal