Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
NCT05690906 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-07-06
Summary
This phase II clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative D2cc dose for rectum during brachytherapy will be recorded and compared.
Conditions
- Uterine Cervical Neoplasms
Interventions
- DEVICE
-
ReSpace™
The experimental group subjects will be injected with ReSpace™ hydrogel.
- DEVICE
-
gauze packing
The subjects of both groups will be given gauze packing
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-12
- Primary Completion
- 2023-07-31
- Completion
- 2023-07-31
Countries
- China
Study Locations
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