Back to resultsA Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Primary Purpose
Ventral Hernia, Incisional Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resorbable Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Ventral Hernia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Beverly Hills Hernia Center
- Cedars-Sinai Medical Center
- Florida Hospital Celebration Health
- Methodist Physicians Clinic
- University Hospitals Case Medical Center
- Oregon Health and Sciences University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Resorbable Mesh
Arm Description
Phasix Mesh
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Device Related Adverse Events
In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Surgical Procedure Time
Measured from incision to closure (skin to skin).
Length of Hospital Stay
Measured from end of index procedure to hospital discharge
Number of Study Related Post Operative Surgical Procedures
Number of Study Related Post Operative New Hospital Admissions
Number of Related Post-operative Visits Unrelated to Standard of Care
Incidence of Seroma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02053168
Brief Title
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Official Title
A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Detailed Description
Pilot Study of patients across all wound classes for recurrence
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resorbable Mesh
Arm Type
Other
Arm Description
Phasix Mesh
Intervention Type
Device
Intervention Name(s)
Resorbable Mesh
Intervention Description
Phasix Mesh
Primary Outcome Measure Information:
Title
Number of Participants With Hernia Recurrence
Description
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.
Time Frame
1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Device Related Adverse Events
Description
In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.
Time Frame
24 Months
Title
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
Description
The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time Frame
Baseline and 24 months postoperative
Title
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
Description
Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time Frame
Baseline and 24 months postoperative
Title
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
Description
Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.
Time Frame
Baseline and 24 months postoperative
Title
Surgical Procedure Time
Description
Measured from incision to closure (skin to skin).
Time Frame
Duration of index procedure (mean of 242.5 mins)
Title
Length of Hospital Stay
Description
Measured from end of index procedure to hospital discharge
Time Frame
10 Months
Title
Number of Study Related Post Operative Surgical Procedures
Time Frame
24 Months
Title
Number of Study Related Post Operative New Hospital Admissions
Time Frame
24 Months
Title
Number of Related Post-operative Visits Unrelated to Standard of Care
Time Frame
24 Months
Title
Incidence of Seroma
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri Novitsky, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beverly Hills Hernia Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Florida Hospital Celebration Health
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Methodist Physicians Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health and Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
We'll reach out to this number within 24 hrs