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The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

NCT05902390 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-06-15

No results posted yet for this study

Summary

This study is an exploratory study based on the previous study " A prospective, multicenter, randomized, parallel arm-controlled, superiority clinical study to evaluate the role of hydrogel spacer in reducing rectal radiation dose in cervical cancer radiation therapy", in which additional follow up study on the subjects of the previous study were conducted. Subjects (6 subjects in Phase I; 100 subjects in Phase II, 50 in the test group and 50 in the control group) who completed the pre-study will be enrolled in this study if they are willing to participate in the long-term follow-up by signing the informed consent form.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DEVICE

hydrogel spacer

Randomly assigned to either the treatment group, who were injected with hydrogel spacer, or the control group, who were not injected with hydrogel spacer.

Sponsors & Collaborators

  • Shanghai Reunion Biotech Co.,Ltd.

    collaborator UNKNOWN

  • 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
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05902390 on ClinicalTrials.gov