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

NCT01981044 | Terminated Results

• 1 other identifier: SURE-007
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia Repair

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

SERI® Surgical Scaffold

EXPERIMENTAL

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

Device: Silk surgical mesh

Interventions

Silk surgical mesh 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

Also known as: SERI® Surgical Scaffold

SERI® Surgical Scaffold

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

• More Information

Results Point of Contact

• Title: Marcio Torre, M.D., M.A., Medical Monitor
• Organization: Allergan Medical

torre_marcio@allergan.com

805-683-6761

Study Officials

• Medical Director

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 11, 2013
• Study Start: September 25, 2013
• Primary Completion: September 25, 2015
• Study Completion: February 24, 2016
• Last Updated: August 26, 2022
• Results First Posted: August 26, 2022

Record last verified: 2022-08

Locations

US (1)