Last reviewed · How we verify
NCT06628219: PRIME
A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis
NA trial testing Symani Surgical System in Open Surgery in 1,000 participants. Not yet recruiting.
1 February 2026
Quick facts
| Lead sponsor | MMI (Medical Microinstruments, Inc.) |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 1,000 |
| Start date | 1 February 2025 |
| Primary completion | 1 February 2026 |
| Estimated completion | 1 February 2030 |
Drugs / interventions tested
- Symani Surgical System
Conditions studied
- Open Surgery — all drugs for Open Surgery →
- Lymphedema — all drugs for Lymphedema →
- Free Tissue Transfer — all drugs for Free Tissue Transfer →
- Microsurgery — all drugs for Microsurgery →
Sponsor
MMI (Medical Microinstruments, Inc.) — full company profile →
Who can join
18 and older, any sex, with Open Surgery or Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery. The primary endpoints are: * Effectiveness: Clinical Success, defined as intraoperative anastomosis patency. * Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments. * Participants will be asked to comply with the follow-up visits as outlined in the protocol.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06628219
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Symani Surgical System
Trials testing the same drug.
- NCT07311876 — Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani · NA · not yet recruiting
- NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
- NCT06866197 — CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System · NA · recruiting
- NCT06725030 — A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling · recruiting
- NCT07140731 — The Symani Restore Study · NA · recruiting
Other recruiting trials for Open Surgery
Currently open trials in the same condition.
- NCT06725030 — A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling · recruiting
- NCT06997419 — Dexamethasone Palmitate for PONV After Open Surgery · NA · recruiting
- NCT07048522 — Perioperative Intravenous Nimodipine Trial · NA · recruiting
Other MMI (Medical Microinstruments, Inc.) trials
Trials by the same sponsor.
- NCT07311876 — Clinical Lymphedema Evaluation - Advancing Reconstruction of Head and Neck Lymphatics With Symani · NA · not yet recruiting
- NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
- NCT06866197 — CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System · NA · recruiting
- NCT07084207 — A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair · NA · recruiting
- NCT06725030 — A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling · recruiting
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 NCT06628219 (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 MMI (Medical Microinstruments, Inc.)
- Last refreshed: 10 December 2024
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/NCT06628219.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing