NCT04016948 - 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)

Gomes RM, Bhandare M, Desouza A, Bal M, Saklani AP
Role of intraoperative frozen section for assessing distal resection margin after anterior resection. Int J Colorectal Dis. 2015 Aug;30(8):1081-9. doi: 10.1007/s00384-015-2244-4. Epub 2015 May 16.
Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF
In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. Epub 2006 Jul 13.
Li WB, Zuo XL, Li CQ, Zuo F, Gu XM, Yu T, Chu CL, Zhang TG, Li YQ
Diagnostic value of confocal laser endomicroscopy for gastric superficial cancerous lesions. Gut. 2011 Mar;60(3):299-306. doi: 10.1136/gut.2010.223586. Epub 2010 Dec 30.
Li Z, Zuo XL, Yu T, Gu XM, Zhou CJ, Li CQ, Ji R, Li YQ
Confocal laser endomicroscopy for in vivo detection of gastric intestinal metaplasia: a randomized controlled trial. Endoscopy. 2014 Apr;46(4):282-90. doi: 10.1055/s-0033-1359215. Epub 2014 Jan 28.
Pech O, Rabenstein T, Manner H, Petrone MC, Pohl J, Vieth M, Stolte M, Ell C
Confocal laser endomicroscopy for in vivo diagnosis of early squamous cell carcinoma in the esophagus. Clin Gastroenterol Hepatol. 2008 Jan;6(1):89-94. Epub 2007 Dec 11.
Rullier E, Laurent C, Bretagnol F, Rullier A, Vendrely V, Zerbib F
Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg. 2005 Mar;241(3):465-9.
Xie XJ, Li CQ, Zuo XL, Yu T, Gu XM, Li Z, Ji R, Wang Q, Li YQ
Differentiation of colonic polyps by confocal laser endomicroscopy. Endoscopy. 2011 Feb;43(2):87-93. doi: 10.1055/s-0030-1255919. Epub 2010 Oct 29.

A Multicenter Randomized Study of Real-time In-vivo Confocal Laser Endomicroscopy Optical Biopsy for Distal Margin in Low Rectal Cancer Compared to Intraoperative Frozen Section

Details for clinical trial NCT04016948

Clinical trial NCT04016948 - References