Phase I Trial: 323476
| ISRCTN | ISRCTN16585188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16585188 |
| Integrated Research Application System (IRAS) | 323476 |
| Central Portfolio Management System (CPMS) | 59146 |
| Sponsor | SAVA Technologies Ltd. |
| Funder | SAVA Technologies Ltd. |
- Submission date
- 10/09/2024
- Registration date
- 13/09/2024
- Last edited
- 20/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved 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
Scientific, Principal investigator
University of Oxford, Diabetes Trial Unit
Oxford
OX3 7LJ
United Kingdom
| enquiries@rdm.ox.ac.uk |
Public
117 Charterhouse Street
London
EC1M 6AA
United Kingdom
| info@sava.health |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-site trial with 50 participants |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | The full scientific title will be published within 30 months after the end of the trial |
| Study objectives | The Health Research Authority (HRA) has approved 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. |
| Ethics approval(s) |
Approved 22/03/2024, London - Dulwich Research Ethics Committee (2nd Floor, 2 Redman Place, London, E20 1JO, United Kingdom; 0207 104 8290; dulwich.rec@hra.nhs.uk), ref: 24/LO/0134 |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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) |
The Health Research Authority (HRA) has approved 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. |
| Completion date | 07/08/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | 24/11/2024 |
| Date of final enrolment | 28/07/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hills Road
Cambridge
CB2 0QQ
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2026: The following changes were made to the study record:
1. The date of first enrolment was changed from 20/09/2024 to 24/11/2024
2. The date of final enrolment was changed from 01/04/2025 to 28/07/2025
15/01/2026: The completion date was changed from 01/06/2025 to 07/08/2025. The deferral expiry date was extended to 30-months from the protocol-defined end-of-study date to 28/04/2028.
10/09/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
