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NCT04500262: COMPULSE
Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
NA trial testing Open-tip pulsed needle biopsy (NeoNavia Biopsy System) in Breast Cancer in 479 participants. Status unknown.
31 March 2024
Quick facts
| Lead sponsor | NeoDynamics AB |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 479 |
| Start date | 13 July 2020 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2025 |
| Sites | 16 locations across United Kingdom |
Drugs / interventions tested
- Open-tip pulsed needle biopsy (NeoNavia Biopsy System)
- Core needle biopsy (CNB)
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
NeoDynamics AB
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to compare performance and safety of a newly developed 14-gauge open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically suspected breast cancer. This is a Sponsor-initiated multicentre randomised trial. At the time of radiological breast cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in the axillary lymph nodes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04500262
- 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.
- NCT03975855 — Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes · 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 NCT04500262 (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: 1 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/NCT04500262.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing