deltatrials
Recruiting PHASE4 INTERVENTIONAL 2-arm NCT07220382

Preoperative BOTOX® Injection for Large Ventral Hernia Repair (PRETOX)

PREoperative Targeted OnabotulinumtoXina Injection for Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor: Joseph and Florence Mandel Family Foundation

Conditions Botox Injection Hernia Hernia Abdominal Wall Hernia Incisional Hernia Incisional Ventral Hernia Repair With Compartment Syndrome Hernia Surgery
Interventions 0.9 % Normal Saline OnabotulinumtoxinA OnabotulinumtoxinA Injection Open Ventral Hernia Repair Saline (placebo) Injection
Updated 2 times since 2025 Last updated: Nov 18, 2025 Started: Nov 3, 2025 Primary completion: Dec 15, 2027 Completion: Dec 15, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Botox Injection and Hernia and is currently actively recruiting participants. Joseph and Florence Mandel Family Foundation leads this study, which shows 2 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshotRecruiting~Dec 2025 – present · 9 months · monthly snapshotRecruiting

Change History

2 versions recorded

  1. Dec 2025 — Present [monthly]

    Recruiting PHASE4

  2. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Joseph and Florence Mandel Family Foundation
  • The Cleveland Clinic
Data source: The Cleveland Clinic

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations