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NCT04435132
Robotic-assisted Percutaneous Access
NA trial testing PCL under fluoroscopy with the aid of the robotic device in Kidney Stone in 5 participants. Completed in 1 November 2018.
1 November 2018
Quick facts
| Lead sponsor | NDR Medical Technology Pte Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 5 |
| Start date | 7 August 2018 |
| Primary completion | 1 November 2018 |
| Estimated completion | 1 November 2018 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- PCL under fluoroscopy with the aid of the robotic device
Conditions studied
- Kidney Stone — all drugs for Kidney Stone →
Sponsor
NDR Medical Technology Pte Ltd
Who can join
Adults 21 to 75, any sex, with Kidney Stone. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a first-in-man (FIM) study to show feasibility and safety profile of the newly developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone disease who had standard indications for prone PCNL were included in the study. PCNL was conducted with percutaneous puncture with the aid of robotic device with the use of intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3 months. Punctures were performed by the board-qualified urologist.
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 NCT04435132
- 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 NCT04435132 (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 NDR Medical Technology Pte Ltd
- Last refreshed: 17 June 2020
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/NCT04435132.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing