Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04906551 |
| Other study ID # |
250444 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2021 |
| Est. completion date |
June 6, 2022 |
Study information
| Verified date |
August 2021 |
| Source |
Birmingham Women's and Children's NHS Foundation Trust |
| Contact |
Sarah Hadfield |
| Phone |
0121 472 1377 |
| Email |
sarah.hadfield2[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
35 participants will be recruited from a list of patients who are scheduled, as part of their
routine NHS care, to have a clinically-indicated outpatient hysteroscopy for assessment of
their uterine cavity. The participants will be women from the age of 18 up to the age of 40
who are undergoing hysteroscopy investigation. All participants included in the study require
at least one ultrasound scan, within the preceding 5 years, demonstrating the presence of a
normal uterine cavity devoid of uterine anomalies such as a septate uterus or intrauterine
fibroids (which may affect endometrial blood flow measurements). It is usual for a patients
to have an ultrasound assessment prior to hysteroscopy therefore we do not anticipate this
requirement limiting the number of eligible participants available.
Description:
Patient registry: Recruited patients will be registered on 'Edge', a secure,
password-protected, database for study participants.
All the investigators will comply with the requirements of the GDPR 2018 with regards to the
storage, processing and disclosure of personal information and will uphold the Act's core
principles.
Access to patient-identifiable data will be restricted to the core patient-facing members of
the research team at Birmingham Women's and Children's Hospital. The patient-facing members
will be the Chief Investigator (ME), the Principal Investigator (JC), and co-investigator
(HH).
The study involves depersonalised data and the data will be maintained within secure servers.
The Birmingham Women's Hospital Research and Development department will hold an archived
copy of the study data.
The Chief Investigator (ME) and the Principal Investigator (JC) will act as data custodians
and keep the site file locked away securely with restricted access to study data for 25
years. Only the aforementioned members of the research team will have access to the site file
for the purpose of quality control, audit and analysis.
Coded, depersonalised data will be created and used for study documents, in place of
participant-identifying information. The participant data within the study and the code
linking this data to the individual's true identity and identifiable data will be kept in
separate locations using encrypted digital files within password-protected folders and
storage media
