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NCT03199456
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
NA trial testing Zip surgical skin closure device in Laceration in 26 participants. Completed in 24 August 2018.
25 July 2018
Quick facts
| Lead sponsor | ZipLine Medical Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 16 June 2017 |
| Primary completion | 25 July 2018 |
| Estimated completion | 24 August 2018 |
| Sites | 2 locations across Sweden |
Drugs / interventions tested
- Zip surgical skin closure device
- Standard of Care sutures
Conditions studied
- Laceration — all drugs for Laceration →
Sponsor
ZipLine Medical Inc.
Who can join
4 and older, any sex, with Laceration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation. The investigation is designed to evaluate the time and cost savings and the satisfaction and outcomes of the Zip device compared to conventional sutures. The subjects will be randomly assigned at a 1:1 ratio to either the Zip Surgical Skin Closure Device group or the Standard of Care sutures group. The investigation consists of one screening/baseline visits at day 0 where the subject will be treated with either the Zip device or sutures, and thereafter two follow up telephone calls at day 10 and day 30. The Zip device/sutures will be removed prior the first follow up call day 10. The duration of the investigation is estimated to 5 months, including a 4-month recruitment period and 1-month follow up period.
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 NCT03199456
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other ZipLine Medical Inc. trials
Trials by the same sponsor.
- NCT04122859 — Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department · NA · unknown
- NCT03178266 — Zip Arthroplasty Patient Satisfaction Evaluation · 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 NCT03199456 (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 ZipLine Medical Inc.
- Last refreshed: 24 September 2018
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/NCT03199456.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing