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NCT07052721
Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery
NA trial testing Experimental Treatment in Rotator Cuff Tears in 50 participants. Enrolling by invitation.
1 May 2026
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 5 September 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 15 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Experimental Treatment
- Sham Comparator
Conditions studied
- Rotator Cuff Tears — all drugs for Rotator Cuff Tears →
- Shoulder Injuries — all drugs for Shoulder Injuries →
- Hallux Valgus — all drugs for Hallux Valgus →
- Ankle Arthropathy — all drugs for Ankle Arthropathy →
Sponsor
University of California, San Diego
Who can join
18 and older, any sex, with Rotator Cuff Tears or Shoulder Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to investigate the post-operative analgesic potential of this investigational device and prepare for a pivotal multicenter clinical trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07052721
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of Experimental Treatment
Trials testing the same drug.
- NCT06818708 — Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery · NA · completed
Other recruiting trials for Rotator Cuff Tears
Currently open trials in the same condition.
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- NCT06918041 — FiberLocker® System Augmentation of Rotator Cuff Repairs · NA · recruiting
- NCT06886932 — Pain Education After Rotator Cuff Surgery · recruiting
- NCT07001566 — The Impact of Cervical Radiculopathy on Functionality in Patients Undergoing Rotator Cuff Repair · recruiting
- NCT06733480 — Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue · NA · recruiting
Other University of California, San Diego trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07052721 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 13 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07052721.
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