Ventral HerniaNCT00866814

Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

An observational study of Ventral Hernia, run by C. R. Bard at 7 sites in United States.

Completed

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

Trial summary

This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventral Hernia
What is being tested?: Bard Ventrio Hernia Patch
Type of treatment: Medical device
How many people: 119 participants
Where: 7 sitesUnited States
Study dates: Mar 2009to May 2011
Phase: Observational
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

Study population: Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.

Who may be able to join

Male or female, age ≥ 18
Be able to undergo study procedures
Have signed an Informed Consent form (ICF)
Be diagnosed with a ventral hernia requiring an open surgery for repair.

Who cannot join

Patient is participating in another device or drug study.
Patient exhibits clinical symptoms indicating infected hernia site.
Patient currently has a clean contaminated or contaminated site.
Patient has a life expectancy less than 2 years at the time of enrollment.
Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Carolinas Medical Center
Charlotte, North Carolina, 28204
RUSH Univeristy Medical Center
Chicago, Illinois
Gaston Memorial Hospital
Gastonia, North Carolina, 28054
Sacred Heart Health System, Inc.
Pensacola, Florida, 32504
Associated Surgical Group
Peoria, Illinois
Sutter Medical Group GNS
Sacramento, California
Novant Clinical Research Institute
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Conditions: Ventral Hernia
Being tested: Bard Ventrio Hernia Patch
Keywords: hernia, open
Medical subject headings: Hernia, Ventral, Hernia

What participants receive

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

Bard Ventrio Hernia PatchDevice
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Study groups in NCT00866814
Study group	Role	What they receive
Ventrio Group		Patients diagnosed with a ventral hernia requiring an open surgery for repair. Receives: Device: Bard Ventrio Hernia Patch

What is being measured

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

The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.
Measured: 1 year post surgery

Secondary outcomes (5)

Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Measured: From the time of surgery to hospital discharge, an average of 1-2 days
Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Measured: Hospital discharge through 21 days post surgery
Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Measured: 22 days post surgery through 1 year post surgery
Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
Mean Quality of Life scores at each study visit for the "sensation of mesh," "pain," and "movement limitation" components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure.
Measured: Baseline and post-surgery at week 2, month 6 and month 12
Procedure Time
Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.
Measured: Day of surgery

Timeline

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

Mar 2009May 2011

First posted23 Mar 2009 (estimated)
Study startMar 2009
Primary completionMay 2011
Study completionMay 2011

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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00866814
Sponsor's protocol ID: DVL-HE004
Status last verified: Oct 2012
First submitted: 20 Mar 2009
Last updated: 12 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch
ClinicalTrials.gov ID: NCT00866814
Acronym / sponsor ID: DVL-HE004
Conditions: Ventral Hernia
Keywords: hernia, open
Study type: Observational
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Collaborators: FGK Clinical Research GmbH
Study start: Mar 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 23 Mar 2009 (estimated)
Results: Posted 21 May 2012

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Ventrio Group	–	Device: Bard Ventrio Hernia PatchPatients diagnosed with a ventral hernia requiring an open surgery for repair.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.

Key inclusion criteria (4 listed)

Male or female, age ≥ 18
Be able to undergo study procedures
Have signed an Informed Consent form (ICF)
Be diagnosed with a ventral hernia requiring an open surgery for repair.

Key exclusion criteria (5 listed)

Patient is participating in another device or drug study.
Patient exhibits clinical symptoms indicating infected hernia site.
Patient currently has a clean contaminated or contaminated site.
Patient has a life expectancy less than 2 years at the time of enrollment.
Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.

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
Bard Ventrio Hernia PatchThe Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.	Device	Ventrio Group

Primary outcome

The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
Time frame: 1 year post surgery
A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.

5 secondary outcomes

Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.
Time frame: From the time of surgery to hospital discharge, an average of 1-2 days
Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.
Time frame: Hospital discharge through 21 days post surgery
Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
Time frame: 22 days post surgery through 1 year post surgery
Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
Time frame: Baseline and post-surgery at week 2, month 6 and month 12
Procedure Time
Time frame: Day of surgery

Results and safety

Results posted to the registry on 21 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ventrio Group	119	99

Primary outcome: The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.

Time frame: 1 year post surgery. Number. Unit: participants

Measure	Ventrio Group n = 119
Value	0

Population analysed: All enrolled patients.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ventrio Group	8 of 119 (6.7%)	14 of 119 (11.8%)	Not reported

Limitations and caveats (from the sponsor): This study was designed as a single arm observational trial without predefined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment comparisons or conclusions can be made.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

David Iannitti, MD, FACS principal investigator

Carolinas Medical Center

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

Questions about this trial

What is this clinical trial studying?

An observational study of Ventral Hernia, run by C. R. Bard at 7 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 4 inclusion and 5 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 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 21 May 2012). 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?

The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. (time frame: 1 year post surgery). 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 NCT00866814.

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 12 Oct 2012.