A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
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ClinicalTrials.gov Identifier: NCT02053168 |
Recruitment Status
:
Completed
First Posted
: February 3, 2014
Last Update Posted
: April 13, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ventral Hernia Incisional Hernia | Device: Resorbable Mesh | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | February 23, 2017 |
Actual Study Completion Date : | February 23, 2017 |

Arm | Intervention/treatment |
---|---|
Resorbable Mesh
Phasix Mesh
|
Device: Resorbable Mesh
Phasix Mesh
|
- Hernia Recurrence Rate [ Time Frame: 12 Months ]
- Device related adverse events [ Time Frame: 24 Months ]
- QOL assessments [ Time Frame: 24 Months ]
- Surgical procedure time [ Time Frame: 10 Months ]
- Length of hospital post Index Procedure [ Time Frame: 10 Months ]
- Length of hospital stay [ Time Frame: 10 Months ]
- Number of study related post operative surgical procedures and admissions. [ Time Frame: 24 Months ]
- Number of study related post operative surgical procedure and admissions [ Time Frame: 24 Months ]
- Number of related post-operative visits unrelated to standard of care [ Time Frame: 24 Months ]
- Incidence of seroma [ Time Frame: 24 Months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053168
United States, California | |
Beverly Hills Hernia Center | |
Beverly Hills, California, United States, 90210 | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Florida | |
Florida Hospital Celebration Health | |
Celebration, Florida, United States, 34747 | |
United States, Nebraska | |
Methodist Physicians Clinic | |
Omaha, Nebraska, United States, 68114 | |
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Oregon Health and Sciences University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Yuri Novitsky, MD | University Hospitals Cleveland Medical Center |
Responsible Party: | C. R. Bard |
ClinicalTrials.gov Identifier: | NCT02053168 History of Changes |
Other Study ID Numbers: |
DVL-HE-015 |
First Posted: | February 3, 2014 Key Record Dates |
Last Update Posted: | April 13, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
Hernia Hernia, Ventral Incisional Hernia Pathological Conditions, Anatomical |
Hernia, Abdominal Postoperative Complications Pathologic Processes |