Ventral HerniaNCT02053168

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

A study testing Resorbable Mesh in people with Ventral Hernia and Incisional Hernia, run by C. R. Bard at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventral Hernia, Incisional Hernia
What is being tested?: Resorbable Mesh
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 6 sitesUnited States
Study dates: Feb 2014to 23 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 15Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Beverly Hills Hernia Center
Beverly Hills, California, 90210
Florida Hospital Celebration Health
Celebration, Florida, 34747
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Methodist Physicians Clinic
Omaha, Nebraska, 68114
Oregon Health and Sciences University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: 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.

Read the detailed description

Pilot Study of patients across all wound classes for recurrence

Conditions: Ventral Hernia, Incisional Hernia
Being tested: Resorbable Mesh
Medical subject headings: Hernia, Ventral, Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Resorbable MeshDevice
Phasix Mesh

Study groups in NCT02053168
Study group	Role	What they receive
Resorbable Mesh	Other	Phasix Mesh Receives: Device: Resorbable Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 24 Months
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.
Measured: Baseline and 24 months postoperative
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.
Measured: Baseline and 24 months postoperative
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.
Measured: Baseline and 24 months postoperative
Surgical Procedure Time
Measured from incision to closure (skin to skin).
Measured: Duration of index procedure (mean of 242.5 mins)
Length of Hospital Stay
Measured from end of index procedure to hospital discharge
Measured: 10 Months
Number of Study Related Post Operative Surgical Procedures
Measured: 24 Months
Number of Study Related Post Operative New Hospital Admissions
Measured: 24 Months
Number of Related Post-operative Visits Unrelated to Standard of Care
Measured: 24 Months
Incidence of Seroma
Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201423 Feb 2017

First posted3 Feb 2014 (estimated)
Study startFeb 2014
Primary completion23 Feb 2017
Study completion23 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ventral HerniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02053168
Sponsor's protocol ID: DVL-HE-015
Status last verified: Apr 2018
First submitted: 31 Jan 2014
Last updated: 11 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair

All Ventral Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
ClinicalTrials.gov ID: NCT02053168
Acronym / sponsor ID: DVL-HE-015
Conditions: Ventral Hernia, Incisional Hernia
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: 23 Feb 2017 (actual)
Study completion: 23 Feb 2017 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 11 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Resorbable Mesh	Other	Device: Resorbable MeshPhasix Mesh

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resorbable MeshPhasix Mesh	Device	Resorbable Mesh

Primary outcome

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.

10 secondary outcomes

Number of Participants With Device Related Adverse Events
Time frame: 24 Months
Carolinas Comfort Scale (CCS) Total Score - Change From Baseline
Time frame: Baseline and 24 months postoperative
Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)
Time frame: Baseline and 24 months postoperative
Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)
Time frame: Baseline and 24 months postoperative
Surgical Procedure Time
Time frame: Duration of index procedure (mean of 242.5 mins)
Length of Hospital Stay
Time frame: 10 Months
Number of Study Related Post Operative Surgical Procedures
Time frame: 24 Months
Number of Study Related Post Operative New Hospital 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

Results and safety

Results posted to the registry on 11 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Resorbable Mesh	25	22

Primary outcome: Number of Participants With Hernia Recurrence

Time frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months. Count of participants. Unit: Participants

Measure	Resorbable Mesh n = 25
1 Month	0
3 Months	0
6 Months	0
12 Months	1
18 Months	0
24 Months	0
>24 Months	1
Post Op to End of Study	2

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 months post index procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Resorbable Mesh	6 of 25 (24%)	6 of 25 (24%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Ventral Hernia

Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuri Novitsky, MD principal investigator

University Hospitals Cleveland Medical Center

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Resorbable Mesh in people with Ventral Hernia and Incisional Hernia, run by C. R. Bard at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hernia Recurrence (time frame: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02053168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.