Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT05690906
Eligibility Criteria:
Inclusion Criteria:
* • Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
* Karnofsky score ≥ 70.
* Subjects aged ≥ 18 years and ≤ 75 years.
* Subjects must be able to cooperate in completing the entire study.
* The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
* No contraindications to CT scanning.
* Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form
Exclusion Criteria:
* •Subjects who have received prior pelvic radiotherapy.
* Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
* Subjects with other primary malignancies
* Subjects with contraindications to radiotherapy, as determined by the investigators
* Subjects with injection site infections.
* Subjects who are allergic to the ingredients of the device.
* Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
* Persons with severe mental illness, cognitive impairment and thinking disorders.
* Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
* Pregnant or lactating women or those who plan to get pregnant within the last six months
* Subjects who cannot be followed up as prescribed by the doctor
* Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05690906
Study Brief:
Protocol Section:
NCT05690906