NCT05690906 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.

A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Study to Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer

Details for clinical trial NCT05690906

Clinical trial NCT05690906 - References