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

Primary Purpose

Ventral Hernia Repair

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silk surgical mesh
Sponsored by
Sofregen Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia Repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SERI® Surgical Scaffold

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of Hernia Recurrence
Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Rate of Hernia Recurrence
Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Rate of Hernia Recurrence
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2013
Last Updated
August 2, 2022
Sponsor
Sofregen Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01981044
Brief Title
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Official Title
A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty accruing patients; business decision
Study Start Date
September 25, 2013 (Actual)
Primary Completion Date
September 25, 2015 (Actual)
Study Completion Date
February 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sofregen Medical, Inc.

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SERI® Surgical Scaffold
Arm Type
Experimental
Arm Description
It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.
Intervention Type
Device
Intervention Name(s)
Silk surgical mesh
Other Intervention Name(s)
SERI® Surgical Scaffold
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of Hernia Recurrence
Description
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
Title
Rate of Hernia Recurrence
Description
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
Title
Rate of Hernia Recurrence
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan Medical
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

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

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