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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01205399
Other study ID # DVL-HE006
Secondary ID
Status Completed
Phase N/A
First received September 17, 2010
Last updated January 13, 2017
Start date September 2010
Est. completion date October 2011

Study information

Verified date January 2017
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Kentucky Medical Center Lexington Kentucky
United States Winthrop Surgical Associates, Inc. Mineola New York
United States Golla Center for Plastic Surgery Pittsburg Pennsylvania
United States Benrus Surgical Associates, Inc Saint Peters Missouri
United States Surgical Associates, Inc. Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 9 + Months
Secondary 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. 9+ Months
Secondary 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). 0 Days
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