Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000040908) titled 'safety study of robotic surgery using DaVinci surgical system in Otolaryngology' on March 31.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - nagoya university
Condition:
Condition - Resectable T1/T2 oropharyngeal cancer or supraglottic cancer or benign tumor in oropharynx or larynx
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - safety evaluation of trans oral robotic surgery(TORS)
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - trans oral surgery with DaVinci surgical system
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Resectable T1/T2 oropharyngeal cancer or supraglottic cancer or benign tumor in oropharynx or larynx.
1) under 20 years old
2) respectable case from February 1, 2019 to March 31, 2021 at Nagoya university hospital
3) No history of radiation therapy
4) No history of chemotherapy or radiation therapy for head and neck cancer except for tongue cancer
5) No history of chemotherapy or radiation therapy for other cancer
6) No simultaneous or metachronism head and neck cancer
Key exclusion criteria - 1) Minor
2) Infectious diseases needed systemic treatment
3) simultaneous or metachronism cancer
4) Fever over 38 degrees
5) pregnant or may be pregnant
6) depression or psychosis
7) unstable angina
8) caa not obtain consent
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2020 Year 03 Month 01 Day
Anticipated trial start date - 2020 Year 04 Month 01 Day
Last follow-up date - 2022 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043979
Disclaimer: Curated by HT Syndication.
