Phase I Study (PHU-001)
| ISRCTN | ISRCTN34438231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34438231 |
| Integrated Research Application System (IRAS) | 346045 |
| Sponsor | Cornerstone Robotics Limited |
| Funder | Cornerstone Robotics Limited |
- Submission date
- 23/01/2026
- Registration date
- 28/01/2026
- Last edited
- 28/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Principal investigator, Public, Scientific
Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust, Southwick Hill Road, Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 2392286000 (Ext. 5421) |
|---|---|
| guglielmo.piozzi@nhs.net |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Historical | |
| Assignment | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Purpose | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Scientific title | Phase I Study (PHU-001) The full scientific title will be published within 30 months after the end of the trial. | |
| Study objectives | ||
| Ethics approval(s) |
Approved 09/01/2026, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 104 8081; bradfordleeds.rec@hra.nhs.uk), ref: 24/YH/0255 | |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Intervention type | Device | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Primary outcome measure(s) |
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. | |
| Key secondary outcome measure(s) | ||
| Completion date | 30/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 20/03/2026 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
27/01/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
