Published
ImpACT-24B Trial
The Lancet · 2019 · PMID 31133406
Sphenopalatine ganglion (SPG) electrical stimulation for acute ischemic stroke. International, randomized, double-blind, sham-controlled pivotal trial. 1,078 patients enrolled across 73 centers.
Published
ImpACT-24M Trial
Stroke · 2019 · PMID 31739771
Refined SPG stimulation for acute ischemic stroke using real-time optical electrode guidance. Prospective, single-arm, open-label study. 50 patients enrolled across 4 centers.
Published
GLAUrious Pivotal Trial
Ophthalmology · 2025 · PMID 40350086
Direct selective laser trabeculoplasty (DSLT) vs. conventional SLT for open-angle glaucoma and ocular hypertension. Prospective, multicenter, randomized, controlled, evaluator-masked noninferiority trial. 192 patients across 14 centers.
Published
CorNeat EverPatch® Pivotal Study
J Clin Med · 2026 · PMID 41976870 · NCT05469867
World's first non-degradable, fully synthetic tissue substitute for ophthalmic surgery. CorNeat EverPatch® is implanted subconjunctivally to conceal glaucoma tube shunts and other artificial ocular implants. Single-arm, open-label pivotal investigation.
Published
GLAUrious Trial Design Paper
BMJ Open Ophthalmology · 2021 / 2023 · PMID 34433548
Protocol and design paper for the GLAUrious RCT comparing BELKIN's Eagle DSLT device against standard SLT. Randomized, controlled, investigator-masked noninferiority design targeting 164 participants.
Completed
EndoArt® Phase 2 Trial
Cornea · 2025 · DOI 10.1097/ICO.0000000000003734 · NCT05139771
Synthetic endothelial layer replacing the failing human endothelium - a permanent, donor-independent alternative to DSAEK and DMEK. Open-label, multicenter Phase 2 safety investigation. 52 patients across 10 sites.
Published
VECTOR-HF I & IIa
European Journal of Heart Failure · 2024
Physician-directed patient self-management of heart failure using the V-LAP implantable left atrial pressure monitoring system. Prospective, single-arm, open-label studies. 13 patients enrolled.
Published
AMEND FIH Cohort
JACC: Cardiovascular Interventions · 2025
Transseptal transcatheter mitral annuloplasty with the Valcare AMEND system. First-in-human cohort reporting 30-day outcomes of a complete semirigid D-shaped ring for mitral regurgitation.
