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| Name | Class |
|---|---|
| Shanghai Reunion Biotech Co.,Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSpace™ | Experimental | The 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSpace™ | Device | All of the subjects will be injected with ReSpace™ hydrogel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation success rate of hydrogel spacer | The success rate of hydrogel spacer implantation will be evaluated by the investigator for subjects. | during procedure |
| Evaluation of device performance of hydrogel spacer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22484226 | Background | 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. | |
| 30237814 | Background | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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:
| 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. | during procedure |
| 31034570 | Background | 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. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |