Integrated CRO + Site Execution in a Multi-Model Surgical Pain Trial

Blinded Phase 3 post-surgical pain study of an investigational implant placed intraoperatively at the surgical site.

Adults undergoing one of the protocol-defined open soft-tissue surgeries.
Post-surgical pain setting with safety and pharmacokinetic evaluation following surgery.
Subjects able to participate in protocol-defined postoperative assessments and follow-up.

97 / 100

Subjects enrolled by ERG sites

‍

Total study sites

‍

Non-ERG sites enrolled zero subjects

Administered by intraoperative placement into the surgical site before closure.

‍

‍

Five ERG sites: Lotus Pasadena, Endeavor Clinical Trials, First Surgical Hospital, Memorial Hermann, and Midwest Clinical Research Center.

‍

Multiple surgery models created variable recruitment pathways, surgeon workflows, perioperative logistics, and postoperative recovery patterns.
Final surgical model, colectomy, was identified as difficult to enroll.
Post-surgical pain endpoints required consistent patient-reported assessments, rescue medication discipline, and protocol adherence across sites.
Site performance was highly concentrated: most non-ERG sites did not enroll subjects.

Lotus served as managing CRO and implemented PRM as an essential study execution strategy.
ERG surgical pain recruitment infrastructure and experienced study teams carried enrollment in a complex surgical study.
PRM supported consistent study conduct and assessment behaviors in a setting vulnerable to placebo-related variability.

‍

For complex surgical pain studies, Lotus CRO oversight with PRM and ERG surgical sites can execute with proven performance.

‍