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Procedure
LiquiBand FIX8® for Inguinal 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
No Placebo-Only Group
Summary
This trial tests two tools for hernia surgery: one uses glue and the other uses tacks. It aims to find out which method is safer and causes less pain for patients with groin hernias. Glue has become an established practice in hernia surgery, significantly helping to reduce the incidence of chronic pain.
Eligible Conditions
- Inguinal Hernia
- Hernia
- Femoral Hernia
- Groin Hernia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-surgery, week 1, week 2, month 1, month 3, month 6, month 9 and month 12 post surgery
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Advanced Medical Solutions Ltd.Lead Sponsor
10 Previous Clinical Trials
1,243 Total Patients Enrolled
John S Roth, MedicinePrincipal InvestigatorUniversity of Kentucky College of Medicine
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