A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

NCT02053168 | Completed Results

• 1 other identifier: DVL-HE-015
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief Summary

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Conditions

Ventral Hernia; Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hernia Recurrence

  A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

  1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months

Secondary Outcomes (10)

• Number of Participants With Device Related Adverse Events

  24 Months

• Carolinas Comfort Scale (CCS) Total Score - Change From Baseline

  Baseline and 24 months postoperative

• Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)

  Baseline and 24 months postoperative

• Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)

  Baseline and 24 months postoperative

• Surgical Procedure Time

  Duration of index procedure (mean of 242.5 mins)

Study Arms (1)

Resorbable Mesh

OTHER

Phasix Mesh

Device: Resorbable Mesh

Interventions

Resorbable Mesh DEVICE

Phasix Mesh

Resorbable Mesh

Eligibility Criteria

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

You may qualify if:

• Subject or subject's legally authorized representative must be willing to give written informed consent
• Subject must be diagnosed with ventral or incisional hernia
• Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

You may not qualify if:

• Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
• Subject's hernia has recurred four or more times.
• Subject's body mass index (BMI) \>40 kg/m2.
• Subject has peritonitis.
• Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
• Chronic steroid use or immunosuppression drugs (\> 6 months).
• Subject has cirrhosis, and/or ascites.
• Subject is American Society of Anesthesiology Class 4 or 5.
• Subject is pregnant or planning to become pregnant during the course of the study.
• Subject is known to be infected with human immunodeficiency virus (HIV).
• Subject has a life expectancy of less than 2 years at the time of enrollment.
• Subject has been treated with an investigational product in the past 30 days.
• Subject is part of the site personnel directly involved with this study
• Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
• Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (6)

Beverly Hills Hernia Center

Beverly Hills, California, 90210, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

Location

Methodist Physicians Clinic

Omaha, Nebraska, 68114, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Dawn Heimer
• Organization: BD Interventional - Surgery

Dawn.Heimer@crbard.com

401-825-8681

Study Officials

• Yuri Novitsky, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

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: January 31, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2014
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-04

Locations

US (6)