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Uterine Cervical NeoplasmsPhase 1NCT05369221

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

A Phase 1 study testing ReSpace™ in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
ReSpace™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
25 Apr 2022to 10 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing

Other trials in China

About this study

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.

Read the 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.

Being tested
ReSpace™
Keywords
Cervical Cancer, hydrogel spacer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReSpace™Device

    All of the subjects will be injected with ReSpace™ hydrogel.

Study groups in NCT05369221
Study groupRoleWhat they receive
ReSpace™ExperimentalThe subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will be enrolled in this study. Subjects will undergo placement of ReSpace™ hydrogel.
Receives: Device: ReSpace™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 21 days post index procedure

Secondary outcomes (3)

  1. Implantation success rate of hydrogel spacer

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

    Measured: during procedure

  2. 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.

    Measured: during procedure

  3. 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.

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2022
  2. Study start25 Apr 2022
  3. Primary completion10 Oct 2023
  4. Study completion10 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05369221
Sponsor's protocol ID
RN-CT-001-1
Status last verified
Oct 2023
First submitted
10 Apr 2022
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • de Freitas AC, Gurgel AP, Chagas BS, Coimbra EC, do Amaral CM. Susceptibility to cervical cancer: an overview. Gynecol Oncol. 2012 Aug;126(2):304-11. doi: 10.1016/j.ygyno.2012.03.047. Epub 2012 Apr 4.

    PubMed 22484226

  • Peach MS, Moore J, Giles W, Trainor J, Long T, Moon N, Hylton JE, Showalter TN, Libby B. Development and preclinical testing of a novel biodegradable hydrogel vaginal packing technology for gynecologic high-dose-rate brachytherapy. J Contemp Brachytherapy. 2018 Aug;10(4):306-314. doi: 10.5114/jcb.2018.77952. Epub 2018 Aug 31.

    PubMed 30237814

  • Kashihara T, Murakami N, Tselis N, Kobayashi K, Tsuchida K, Shima S, Masui K, Yoshida K, Takahashi K, Inaba K, Umezawa R, Igaki H, Ito Y, Kato T, Uno T, Itami J. Hyaluronate gel injection for rectum dose reduction in gynecologic high-dose-rate brachytherapy: initial Japanese experience. J Radiat Res. 2019 Jul 1;60(4):501-508. doi: 10.1093/jrr/rrz016.

    PubMed 31034570

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ReSpace™ in people with Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The cumulative D2cc dose for rectum during brachytherapy (time frame: 21 days post index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05369221, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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