Last reviewed · How we verify
NCT05163548
PerQseal®+ Early Feasibility Study
NA trial testing PerQseal Plus Device in Percutaneous Large Hole Vascular Closure in 15 participants. Completed in 7 July 2022.
7 July 2022
Quick facts
| Lead sponsor | Vivasure Medical Limited |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 8 March 2022 |
| Primary completion | 7 July 2022 |
| Estimated completion | 7 July 2022 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- PerQseal Plus Device
Conditions studied
- Percutaneous Large Hole Vascular Closure — all drugs for Percutaneous Large Hole Vascular Closure →
Sponsor
Vivasure Medical Limited
Who can join
19 and older, any sex, with Percutaneous Large Hole Vascular Closure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05163548
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Vivasure Medical Limited trials
Trials by the same sponsor.
- NCT04818541 — PerQseal® Impella Early Feasibility Study · NA · completed
- NCT04799769 — Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study · NA · unknown
- NCT03423602 — Safety and Performance Study of Large Hole Vascular Closure Device FIV · NA · completed
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 NCT05163548 (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 Vivasure Medical Limited
- Last refreshed: 26 April 2023
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/NCT05163548.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing