Trials / Completed
CompletedNCT05369221
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
In this study, 5 subjects will be enrolled and the cumulative D2cc dose for rectum during brachytherapy will be recorded as the primary outcome measures.
Detailed description
This is a phase I prospective study of 5 patients to determine if PEG hydrogel (ReSpace™) reduces the radiation dose delivered to the rectum during radiation therapy for cervical cancer by increasing the space between the cervix and the anterior rectal wall. In the other word, the purpose of this study is to assess whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReSpace™ | All of the subjects will be injected with ReSpace™ hydrogel. |
Timeline
- Start date
- 2022-04-25
- Primary completion
- 2023-10-10
- Completion
- 2023-10-10
- First posted
- 2022-05-11
- Last updated
- 2023-11-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05369221. Inclusion in this directory is not an endorsement.