NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
| NCT ID | NCT07191067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Synaptrix, Inc. |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-09-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
Eligibility Criteria
Inclusion Criteria: 1. Male or non-pregnant females age ≥ 21 years of age; 2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines; 3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI); 4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days. 5. Able to read and understand instructions and information presented in English. Exclusion Criteria: 1. Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure; 2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure; 3. History of substance abuse or misuse; 4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities); 5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee; 6. Prior TKA on the operative knee; 7. BMI \> 40; 8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions; 9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator); 10. History of hip or knee dislocation or bone fractures on the operative leg; 11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin; 12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \>10) or depression (PHQ-9 score \>15); 13. Pregnant, actively planning a pregnancy or breast-feeding a child; 14. Uncontrolled diabetes (A1C \> 7.5%); 15. History of bleeding disorder; 16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07191067 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07191067 currently recruiting?
Yes, NCT07191067 is actively recruiting participants. Contact the research team at dan.guerrero@synaptrix.net for enrollment information.
Where is the NCT07191067 trial being conducted?
This trial is being conducted at Daphne, United States, Williamsville, United States, Chapel Hill, United States, Medford, United States and 1 additional location.
Who is sponsoring the NCT07191067 clinical trial?
NCT07191067 is sponsored by Synaptrix, Inc.. The trial plans to enroll 120 participants.