Phasix™ Mesh for Open Laparotomy

Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Open LaparotomyPhasix™ Mesh - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if the Phasix Mesh implant prevents incisional hernias better than just using regular stitches.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

0 Primary · 7 Secondary · Reporting Duration: 60-months

60-Months
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)
Rate of Device-related Adverse Events (AEs)
Incisional hernia
60-months
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
Study Day 0
Length of surgical procedure in minutes
Length of time for wound closure in minutes
Day 3
Length of hospital stay in days

Trial Safety

Phase-Based Safety

1 of 3

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VenaSeal™ Closure System
2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Primary Suture Closure
1 of 2
Phasix™ Mesh
1 of 2

Active Control

Experimental Treatment

477 Total Participants · 2 Treatment Groups

Primary Treatment: Phasix™ Mesh · No Placebo Group · N/A

Phasix™ Mesh
Device
Experimental Group · 1 Intervention: Phasix™ Mesh · Intervention Types: Device
Primary Suture ClosureNoIntervention Group · 1 Intervention: Primary Suture Closure · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phasix™ Mesh
2016
N/A
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60-months

Who is running the clinical trial?

C. R. BardLead Sponsor
102 Previous Clinical Trials
38,945 Total Patients Enrolled
William Hope, MDPrincipal InvestigatorNew Hanover Regional Medical Center
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a high risk of developing a hernia.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
University of California San Francisco100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Are additional volunteers sought for this trial?

"Affirmative. Clinicaltrials.gov indicates that the recruitment for this trial is ongoing, with registration starting on December 12th 2019 and being updated as recently as October 24th 2022. 477 participants are required from 17 sites around the nation." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment rate for participants in this research project?

"This medical trial necessitates 477 participants who qualify for the set inclusion criteria to join. Potential candidates can locate participating sites in both Peoria, Illinois (OSF Saint Francis Medical Center) and Omaha, Nebraska (Nebraska Medical Centre)." - Anonymous Online Contributor

Unverified Answer

How many facilities are presently conducting this research trial?

"Presently, 17 sites are running the clinical trial. These locations span from Peoria to Omaha and Bronx as well as 14 other locales. It is prudent for participants to select a site that minimizes their travel burden if they decide to enroll." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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