Last updated: July 4, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Cervical Cancer
Uterine Disorders
Treatment
gauze packing
ReSpace™
Clinical Study ID
NCT05690906
RN-CT-001-2
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- • Patients with pathologically confirmed cervical cancer who must be scheduled toundergo radical radiotherapy by means of intensity-modulated radiotherapy combinedwith 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 implantsand can tolerate MRI.
- No contraindications to CT scanning.
- Subjects must be able to understand the purpose of the trial, voluntarilyparticipate and sign an informed consent form
Exclusion
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 theinvestigators
- 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 processand 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 1month prior to screening
- Pregnant or lactating women or those who plan to get pregnant within the last sixmonths
- Subjects who cannot be followed up as prescribed by the doctor
- Other conditions that, in the judgment of the investigator, make the subjectunsuitable for enrollmen
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: gauze packing
Phase: 2
Study Start date:
July 12, 2022
Estimated Completion Date:
July 31, 2023
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing
ChinaActive - Recruiting

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