Last reviewed · How we verify

NCT02269020: RoboCurage ORL

Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx

Completed Phase 1 Last updated 11 January 2019
What this trial tests

Phase 1 trial testing Neck Dissection in Carcinoma, Squamous Cell in 3 participants. Completed in 14 September 2017.

Timeline
16 February 2015
Primary endpoint
4 September 2017
14 September 2017

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nīmes
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date16 February 2015
Primary completion4 September 2017
Estimated completion14 September 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

Adults 18 to 89, any sex, with Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety. Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. [Robotic Surgery - Who is The Boss?]
    Schuler PJ. · · 2018 · cited 6× · PMID 29905359 · DOI 10.1055/s-0043-121791

Verify or expand the search:

Other trials of Neck Dissection

Trials testing the same drug.

Other recruiting trials for Carcinoma, Squamous Cell

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Nīmes trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02269020.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing