Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04191031 · ClinicalTrials.gov registry record · NA
Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
A NA study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT04191031: Clinical Trial NA study, sponsored by Pacira Pharmaceuticals.
NCT04191031 is a NA study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191031, a NA study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA
Interventions
- DEVICE ioveraº
- DEVICE ioveraº sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2022-07-12 |
| Phase | NA |
Why NCT04191031 stopped before completion
NCT04191031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which ioveraº is the first listed.
NCT04191031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04191031 about?
NCT04191031 is a clinical study titled "Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty". Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergo...
What is the current status of trial NCT04191031?
This trial is currently terminated. It is a NA study. The enrollment target is 79 participants. The study started on 2020-09-30. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT04191031?
The interventions under investigation include: ioveraº (DEVICE), ioveraº sham (DEVICE).
Who is sponsoring clinical trial NCT04191031?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191031's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05798897 · 79 participants · Phase 1
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
- NCT06042439 · 79 participants · NA
AM vs PM Exercise Training
- NCT06223555 · 79 participants · NA
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI