M24-846 Ventral Hernia Repair Study

A research study evaluating whether an investigational medication injected into abdominal wall muscles before surgery can improve outcomes for patients undergoing ventral hernia repair.

Category
Bones, Joints, and Muscles Diagnosis and Treatment Technologies Liver and Digestive System
Age Requirement
Adults (18 years and older)

About This Study

Summary

A Phase 2 randomized clinical trial evaluating the safety and effectiveness of AGN-151607-DP (gemibotulinumtoxinA) in adults undergoing open abdominal ventral hernia repair. The medication is injected into abdominal wall muscles prior to surgery to increase muscle relaxation and improve the likelihood of achieving primary fascial closure without the need for component separation techniques. Approximately 200 participants will be enrolled at up to 30 sites in the U.S.

To be included in M24-846, participants must be / have

  • 18 – 80 years old 
  • A midline ventral hernia requiring open surgical repair 
  • A hernia defect width between 6 cm and 18 cm 
  • Able to provide informed consent and comply with study procedures
  • Negative pregnancy test for women of childbearing potential

To be included in M24-846, participants must not be / have

  • Certain neuromuscular disorders (e.g., myasthenia gravis, ALS) 
  • Recent respiratory complications or severe pulmonary disease 
  • Contraindications or hypersensitivity to botulinum toxin 
  • BMI greater than 40 kg/m² 
  • Used botulinum neurotoxin within 16 weeks prior to day
Keywords 
Ventral hernia; Abdominal wall surgery; Botulinum toxin; Hernia repair; Abdominal wall reconstruction

For More About This Study or To Ask About Participation

Miebaka Roberts, MBBS, MPH
Senior Research Associate, Department of Surgery

Additional Information

Lead scientist at Carilion Clinc

Curtis E. Bower, MD

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Dr. Curtis E. Bower is a general surgeon at Carilion Clinic and Chief of General and Breast Surgery. He specializes in minimally invasive surgical techniques and has extensive experience treating hernias and other gastrointestinal conditions. Dr. Bower graduated from Jefferson Medical College and completed training at East Carolina University.

Curtis E. Bower, MD

Official title of study

A Phase 2 Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of AGN-151607-DP (gemibotulinumtoxinA) for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair

Funding mechanism

Industry sponsored by AbbVie Inc.

National Clinical Trials listing

IRB approval number and responsible organization

IRB-26-2329 Carilion Clinic

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