Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space

NCT05369221CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

8

Start Date

2022-04-25

Completion Date

2023-10-10

Study Type

INTERVENTIONAL

Official Title

Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space

Interventions

ReSpace™

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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 enrollment

Outcome Measures

Primary Outcomes

The cumulative D2cc dose for rectum during brachytherapy

The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects. which will be used to validate the parameter selection for phase II sample size estimation.

Time frame: 21 days post index procedure

Secondary Outcomes

Implantation success rate of hydrogel spacer

The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects.

Time frame: during procedure

Evaluation of device performance of hydrogel spacer

The ease of use of the test device will be evaluated by the investigator on the day of Operation. The evaluation items are as follows: 1. Whether the device is easy to assemble. 2. Whether the process of positioning the needle is smooth and whether it is easy to position the needle. 3. Whether the device is easy to inject and whether the injection process is smooth.

Time frame: during procedure

Injection volume of hydrogel spacer

Recording the amount of hydrogel spacer injected in the subjects,which will be used to evaluate the reasonableness of the injected dose of ReSpace™ when hydrogel is injected between the rectum and cervix in women undergoing radiation therapy.

Time frame: during procedure

Locations

Peking Union Medical College Hospital, Beijing, China