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NCT03975855: PULSE
Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
trial testing NeoNavia® Biopsy System in Breast Cancer in 140 participants. Completed in 11 April 2023.
30 June 2021
Quick facts
| Lead sponsor | NeoDynamics AB |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 140 |
| Start date | 14 February 2019 |
| Primary completion | 30 June 2021 |
| Estimated completion | 11 April 2023 |
| Sites | 7 locations across Germany |
Drugs / interventions tested
- NeoNavia® Biopsy System
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
NeoDynamics AB
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to document performance characteristics of a biopsy device indicated for use in axillary lymph nodes, to provide basic insights into the complexity of axillary biopsy procedures and generate hypothesis for further larger comparative trials. This is a Sponsor-initiated prospective, multicenter, registry trial. Patients that present with suspicious axillary lymph nodes at the time of breast cancer diagnosis undergo axillary sampling using the NeoNavia biopsy system. This is in accordance with clinical routine and current clinical guidelines. The system incorporates a new mechanism for controllable and precise needle insertion and a newly developed sampling needle for high yield sampling acquisition. It is approved for use in the breast and axillary lymph nodes.
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 NCT03975855
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other NeoDynamics AB trials
Trials by the same sponsor.
- NCT04500262 — Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes · NA · unknown
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 NCT03975855 (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 NeoDynamics AB
- Last refreshed: 6 June 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/NCT03975855.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing