Last reviewed · How we verify
NCT03374735
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
NA trial testing SETALUM™ Sealant in Vascular Diseases in 22 participants. Completed in 3 October 2017.
7 February 2017
Quick facts
| Lead sponsor | Gecko Biomedical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 15 March 2016 |
| Primary completion | 7 February 2017 |
| Estimated completion | 3 October 2017 |
Drugs / interventions tested
- SETALUM™ Sealant
Conditions studied
- Vascular Diseases — all drugs for Vascular Diseases →
Sponsor
Gecko Biomedical
Who can join
18 and older, any sex, with Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.
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 NCT03374735
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03374735 (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 Gecko Biomedical
- Last refreshed: 15 December 2017
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/NCT03374735.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing