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Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance


N/A
18 Years
90 Years
Open (Enrolling)
Both
Laryngeal Neoplasms

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Trial Information

Observational Study on Surgical Treatment of Early Stage (T1-T2) Glotto-supraglottic Laryngeal Cancer Via Transoral Resection With Robotic Assistance


Inclusion Criteria:



- The subject has signed consent

- The subject must be a member or beneficiary of a health insurance plan

- The patient is available for 12 months of follow-up

- The subject has a cancer of the larynx:

- classified T1 or T2 in the TNM

- glottic localization and / or supraglottic regardless of node status

- with or without a history of head and neck cancer

- The subject does not have distant metastasis (M0)

- A decision for endoscopic robot-assisted surgery is retained in multidisciplinary
meeting

Exclusion Criteria:

-

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The presence/absence of cancerous tissue in the surgical margins of the resectioned tumors

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Benjamin Lallemant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AOI/2010/BL-01

NCT ID:

NCT01257633

Start Date:

April 2011

Completion Date:

February 2015

Related Keywords:

  • Laryngeal Neoplasms
  • da Vinci surgical robot
  • laryngeal cancer
  • Neoplasms
  • Laryngeal Neoplasms

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