HerniaAlloMaxNCT01205399

A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

An observational study of Hernia, run by C. R. Bard at 5 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 enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hernia
How many people: 78 participants
Where: 5 sitesUnited States
Study dates: Sep 2010to Oct 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 who have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

Who may be able to join

Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
Have signed an informed consent form (ICF).

Who cannot join

Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Benrus Surgical Associates, Inc
City of Saint Peters, Missouri, 63376
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Winthrop Surgical Associates, Inc.
Mineola, New York, 11501
Golla Center for Plastic Surgery
Pittsburgh, Pennsylvania, 15238
Surgical Associates, Inc.
Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Read the detailed description

Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.

Conditions: Hernia
Medical subject headings: Hernia

What participants receive

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

Study groups in NCT01205399
Study group	Role	What they receive
AlloMax Surgical Graft Group		Not described

What is being measured

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

Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
Measured: 9 + Months

Secondary outcomes (2)

Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.
Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit.
Measured: 9+ Months
Procedural Time for AlloMax Surgical Graft Placement.
Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).
Measured: 0 Days

Timeline

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

Sep 2010Oct 2011

First posted20 Sep 2010 (estimated)
Study startSep 2010
Primary completionOct 2011
Study completionOct 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 HerniaStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
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: Cohort
Time perspective: Cross-sectional
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01205399
Sponsor's protocol ID: DVL-HE006
Acronym: AlloMax
Status last verified: Jan 2017
First submitted: 17 Sep 2010
Last updated: 18 Jan 2017
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

Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain

All Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
ClinicalTrials.gov ID: NCT01205399
Acronym / sponsor ID: AlloMax / DVL-HE006
Conditions: Hernia
Study type: Observational
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 20 Sep 2010 (estimated)
Results: Posted 23 Aug 2012

Clinical summary

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

This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

Detailed description

Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
AlloMax Surgical Graft Group	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

Key inclusion criteria (2 listed)

Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
Have signed an informed consent form (ICF).

Key exclusion criteria (2 listed)

Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.

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

Primary outcome

Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
Time frame: 9 + Months
A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.

2 secondary outcomes

Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.
Time frame: 9+ Months
Procedural Time for AlloMax Surgical Graft Placement.
Time frame: 0 Days

Results and safety

Results posted to the registry on 23 Aug 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
AlloMax Surgical Graft Group	78	78

Primary outcome: Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft

Time frame: 9 + Months. Number. Unit: participants

Measure	AlloMax Surgical Graft Group n = 78
Value	17

Population analysed: All enrolled subjects that could be verified through historical medical record review.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AlloMax Surgical Graft Group	50 of 78 (64.1%)	46 of 78 (59%)	Not reported

Limitations and caveats (from the sponsor): Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single arm, observational study design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hernia

Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain

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.

John S Roth, MD principal investigator

University of Kentucky

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, run by C. R. Bard at 5 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 2 inclusion and 2 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 23 Aug 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?

Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft (time frame: 9 + 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 NCT01205399.

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 18 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.