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ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
High-Throughput Abdominoplasty Pain Trial Execution
A randomized, double-blind, placebo-controlled Phase 3 study of an implant placed intraoperatively at the surgical site in planned abdominoplasty.
- Adults undergoing elective, nonemergency abdominoplasty
- Rectus sheath plication required
- Incision did not extend above the umbilicus
366
Subjects Enrolled
5
ERG Sites
>11
SSM Average
Study Model
- Planned abdominoplasty with rectus sheath plication
- Standard surgical technique under general anesthesia
- Approximately 4-day inpatient period + follow-up through Day 30
Product/Route
Three investigational implants vs placebo implants placed intraoperatively in the surgical site before incision closure
Challenges
- Subjective pain endpoint requiring repeated NPRS assessments through 72 hours
- Rescue medication use and opioid-free endpoints required careful coordination
- Wound healing and systemic toxicity assessments through follow-up
Differentiators
- Five experienced ERG surgical pain sites: Lotus Clinical Research, Midwest Clinical Research Center, two HD Research sites, and Endeavor Clinical Trials
- ERG industry leading infrastructure for acute pain trial execution and enrollment
- Integrated CRO + site model with PRM built into execution
