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Procedure

LiquiBand FIX8® for Groin Hernia

N/A
Waitlist Available
Led By John S Roth, Medicine
Research Sponsored by Advanced Medical Solutions Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery, week 1, week 2, month 1, month 3, month 6, month 9 and month 12 post surgery
Awards & highlights

Study Summary

This trial is testing a new medical device to see if it is more effective and safe than the current standard device for a laparoscopic groin hernia repair. The new device is the LiquiBand FIX8® and the current standard device is the tack-based control device (AbsorbaTack™). The primary outcome measure is an improvement in pain score measured by VAS at 6 months.

Eligible Conditions
  • Groin Hernia
  • Femoral Hernia
  • Inguinal Hernia
  • Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery, week 1, week 2, month 1, month 3, month 6, month 9 and month 12 post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery, week 1, week 2, month 1, month 3, month 6, month 9 and month 12 post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain
Secondary outcome measures
Incidence of Successful Peritoneal Closure (TAPP Repairs Only)
Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).
Number of Participants With Hernia Recurrence
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LiquiBand FIX8®Experimental Treatment1 Intervention
LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
Group II: AbsorbaTack™Active Control1 Intervention
AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LiquiBand FIX8®
2019
N/A
~290

Find a Location

Who is running the clinical trial?

Advanced Medical Solutions Ltd.Lead Sponsor
10 Previous Clinical Trials
1,242 Total Patients Enrolled
John S Roth, MedicinePrincipal InvestigatorUniversity of Kentucky College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
2019. "A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™ for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04009213.
~50 spots leftby Apr 2025
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