NCT01863030

Brief Summary

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:

  1. 1.Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
  2. 2.Perioperative, short-term and long-term procedural and/or device related complications.
  3. 3.Abdominal Wall Function and mobility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

May 14, 2013

Results QC Date

July 4, 2017

Last Update Submit

January 17, 2020

Conditions

Ventral Hernia

Keywords

Resorbable meshPhasix mesh

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh

    Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.

    up to 24 months post surgery

Other Outcomes (12)

  • Physical Component Summery

    baseline, 12 months, 24 months

  • Role Emotional Quality of Life Outcome

    baseline, 12 months, 24 months

  • Physical Functioning Quality of Life Outcome

    baseline, 12 months, 24 months

  • +9 more other outcomes

Study Arms (1)

Phasix mesh

Mesh being used for approved use. Mesh for ventral and incisional hernias.

Device: Phasix mesh implant

Interventions

Phasix mesh implantDEVICE
Phasix mesh

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patents with ventral hernias that meet eligibility criteria.

You may qualify if:

  • The subject must meet all of the relevant criteria listed below to be enrolled in the study:
  • Subject must be ≥18 years of age.
  • Subject or subject's legally authorized representative must be willing give written informed consent.
  • Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
  • Hernia size greater than 10cm2 and less than 250cm2
  • Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

You may not qualify if:

  • The subject must be excluded from study enrollment if any of the following criteria are met:
  • Subject's hernia is multiply recurrent.
  • CDC wound classification other than clean or clean-contaminated
  • The use of surgical repair as a bridge.
  • Patient has a contraindication to placement of mesh.
  • Concomitant procedures with wound classification other than clean
  • Subject has peritonitis.
  • Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
  • Subject's body mass index (BMI) \>55 kg/m2.
  • Subject has cirrhosis, and/or ascites.
  • Subject is American Society of Anesthesiology Class 4 or 5.
  • Subject is known to be infected with human immunodeficiency virus (HIV).
  • Subject has known allergies to tetracycline or kanamycin.
  • Subject has a life expectancy of less than 2 years at the time of enrollment.
  • Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • Plymale MA, Davenport DL, Dugan A, Zachem A, Roth JS. Ventral hernia repair with poly-4-hydroxybutyrate mesh. Surg Endosc. 2018 Apr;32(4):1689-1694. doi: 10.1007/s00464-017-5848-7. Epub 2017 Sep 15.

    PMID: 28916979DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Scott Roth M.D.
Organization
University of Kentucky Medical Center
sroth@uky.edu
859-323-6346

Study Officials

  • John S Roth, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 27, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 21, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)