NCT01187160

Brief Summary

The purpose of this study is to assess if the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) allows for "adequate exposure" for transoral resection of hypertrophic lingual tonsils in patients with obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

February 19, 2010

Last Update Submit

August 18, 2016

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • To assess if the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) allows for "adequate exposure" for transoral resection of hypertrophic lingual tonsils in patients with obstructive sleep apnea.

    1 year

Secondary Outcomes (4)

  • To assess ability to perform the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.

    1 year

  • To assess operative time to perform the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.

    1 year

  • To assess blood loss during the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.

    1 year

  • To assess complications of the transoral diagnostic removal of hypertrophic lingual tonsils using the robotic system for transoral resection of the tongue base in patients with obstructive sleep apnea.

    1 year

Study Arms (1)

Transoral robotic surgery (TORS)

EXPERIMENTAL

da Vinci® Robotic Surgical System

Procedure: Transoral robotic surgery (TORS)

Interventions

Transoral robotic surgery (TORS)PROCEDURE

The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a manual image-guided surgery system that is computer enhanced rather than computer guided robotic surgery in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a milling device). Use of the da Vinci® Robotic Surgical System in the aforementioned configuration in fact facilitates an exact translation of the surgeons hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Also known as: da Vinci® Robotic Surgical System
Transoral robotic surgery (TORS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 or older at time of treatment.
  • Patient must present with indications for surgical management of the tongue base to treat obstructive sleep apnea.
  • Written informed consent and/or consent waiver by IRB.

You may not qualify if:

  • Unexplained fever and/or untreated, active infection.
  • Patient pregnancy.
  • Previous head and neck surgery precluding transoral/robotic procedures.
  • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches.
  • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Erica Thaler, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2010

First Posted

August 23, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

US(1)