- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053168
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
April 10, 2018 updated by: C. R. Bard
A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pilot Study of patients across all wound classes for recurrence
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Beverly Hills, California, United States, 90210
- Beverly Hills Hernia Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Florida
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Celebration, Florida, United States, 34747
- Florida Hospital Celebration Health
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Nebraska
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Omaha, Nebraska, United States, 68114
- Methodist Physicians Clinic
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Sciences University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Resorbable Mesh
Phasix Mesh
|
Phasix Mesh
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Hernia Recurrence
Time Frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
|
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.
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1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Device Related Adverse Events
Time Frame: 24 Months
|
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.
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24 Months
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Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
Time Frame: Baseline and 24 months postoperative
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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.
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Baseline and 24 months postoperative
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Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
Time Frame: Baseline and 24 months postoperative
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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.
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Baseline and 24 months postoperative
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Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
Time Frame: Baseline and 24 months postoperative
|
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.
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Baseline and 24 months postoperative
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Surgical Procedure Time
Time Frame: Duration of index procedure (mean of 242.5 mins)
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Measured from incision to closure (skin to skin).
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Duration of index procedure (mean of 242.5 mins)
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Length of Hospital Stay
Time Frame: 10 Months
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Measured from end of index procedure to hospital discharge
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10 Months
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Number of Study Related Post Operative Surgical Procedures
Time Frame: 24 Months
|
24 Months
|
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Number of Study Related Post Operative New Hospital Admissions
Time Frame: 24 Months
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24 Months
|
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Number of Related Post-operative Visits Unrelated to Standard of Care
Time Frame: 24 Months
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24 Months
|
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Incidence of Seroma
Time Frame: 24 Months
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24 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuri Novitsky, MD, University Hospitals Cleveland Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 23, 2017
Study Completion (Actual)
February 23, 2017
Study Registration Dates
First Submitted
January 31, 2014
First Submitted That Met QC Criteria
January 31, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVL-HE-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventral Hernia
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Varazdin General HospitalCompletedIncisional Ventral Hernia | Recurrent Ventral HerniaCroatia
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Anne Arundel Health System Research InstituteMedtronic - MITGCompletedGrade I Ventral Hernia | Grade II Ventral HerniaUnited States
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University Hospital, Strasbourg, FranceRecruitingVentral Hernia RepairFrance
-
Makassed General HospitalSuspended
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Sofregen Medical, Inc.TerminatedVentral Hernia RepairUnited States
-
Zaza DemetrashviliRecruitingLarge Midline Ventral HerniaGeorgia
-
Hvidovre University HospitalUniversity of CopenhagenCompleted
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Hvidovre University HospitalCopenhagen University Hospital at HerlevCompleted
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Hospices Civils de LyonRecruiting
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Medtronic - MITGCompletedVentral Incisional HerniaFrance
Clinical Trials on Resorbable Mesh
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University Hospital, GhentNovus ScientificCompletedPrimary and Secondary Ventral HerniaUnited Kingdom, Belgium, Denmark, Poland, Spain
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C. R. BardFGK Clinical Research GmbHCompletedVentral Hernia | Incisional HerniaUnited States
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Medtronic - MITGRecruitingIncisional Hernia | Incisional Hernia of Midline of Abdomen | Midline LaparotomySpain, United Kingdom, Netherlands, Croatia, Germany
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Medtronic - MITGNot yet recruitingHernia | Hernia, Abdominal | Hernia, Ventral | Hernia Abdominal Wall
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University Hospital, GenevaRecruitingIncisional HerniaSwitzerland
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Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
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Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
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Hospices Civils de LyonUnknownMaxillo-Facial SurgeryFrance
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Ospedale Santa Croce-Carle CuneoAzienda Ospedaliera di Padova; S. Andrea Hospital; San Giuseppe Moscati Hospital and other collaboratorsUnknown
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Blokhin's Russian Cancer Research CenterRecruitingRectal Cancer | Surgery | Neoplasms Malignant | Hernia IncisionalRussian Federation