Obstructive Sleep ApneaNCT01187160
Transoral Robotic Surgery (TORS) for Sleep Apnea
A study testing Transoral robotic surgery (TORS) in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Transoral robotic surgery (TORS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-operative exclusion criteria:
- 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.
- Intra-operative exclusion criteria (It is recognized that sometimes patients cannot be excluded from study participation until prepared in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting):
- Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study Assessing Surgical Exposure During Transoral Robotic Surgery (TORS) for Sleep Apnea Using the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA)
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.
Read the detailed description
Visit 1 - Outpatient Clinical Setting. The patient will be evaluated prior to treatment in the outpatient clinical setting in a way which is consistent for routine workup prior to any surgery of the tongue base for sleep apnea. This will include sleep nasendoscopy (see below), and if it is predicted pre-treatment that the transoral robotic approach may be appropriate then the patient will be given the option of participating in the study. This will include a review of the patient's pre-operative sleep study and a nasopharyngolaryngoscopic exam to assess for lingual tonsillar hypertrophy. A pre-operative MRI will be obtained to provide quantitative measurement of the patient's tongue base hypertrophy.
Visit 2 - Sleep Nasendoscopy. The patient will undergo sleep nasendoscopy as outlined below, in order to assess the involvement of the tongue base in the patient's sleep disordered breathing. This is a routine diagnostic procedure. Patients are pharmacologically induced into a light phase of sleep and the upper airway is visualized directly with a nasopharyngolaryngoscope. Anesthetic management will be performed in standard fashion, using propofol titrated to an endpoint of moderate sedation, as is typically done for procedural sedation in esophagogastroduodenoscopy. Administration will be logged to permit analysis of dosing requirements. Respiratory pattern will be monitored noninvasively and logged to permit correlation of obstruction to propofol administration.
Visit 3 - Intraoperative Setting. The patient will undergo an evaluation for "adequate exposure" for transoral robotic surgery and if "adequate exposure" is achieved then they will undergo transoral robotic surgery for lingual tonsillar hypertrophy to treat obstructive sleep apnea.
Visit 4 - Postoperative Setting. This will be in the inpatient and/or outpatient setting within three weeks of surgical procedure. The patient will undergo routine postoperative clinical evaluation.
Visit 5 - Postoperative Testing. The patient will undergo a follow-up sleep study to determine efficacy of the surgical procedure at three months post-operatively, the standard interval used to determine the outcome of the procedure.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Transoral robotic surgery (TORS)
- Keywords
- Obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral robotic surgery (TORS)Procedure or surgery
Also called da Vinci® Robotic Surgical System
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.
| Study group | Role | What they receive |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | da Vinci® Robotic Surgical System Receives: Procedure: Transoral robotic surgery (TORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Thaler, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187160
- Sponsor's protocol ID
- 809623
- Status last verified
- Aug 2016
- First submitted
- 19 Feb 2010
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Surgical Exposure During Transoral Robotic Surgery (TORS) for Sleep Apnea Using the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA)
- ClinicalTrials.gov ID
- NCT01187160
- Acronym / sponsor ID
- 809623
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visit 1 - Outpatient Clinical Setting. The patient will be evaluated prior to treatment in the outpatient clinical setting in a way which is consistent for routine workup prior to any surgery of the tongue base for sleep apnea. This will include sleep nasendoscopy (see below), and if it is predicted pre-treatment that the transoral robotic approach may be appropriate then the patient will be given the option of participating in the study. This will include a review of the patient's pre-operative sleep study and a nasopharyngolaryngoscopic exam to assess for lingual tonsillar hypertrophy. A pre-operative MRI will be obtained to provide quantitative measurement of the patient's tongue base hypertrophy.
Visit 2 - Sleep Nasendoscopy. The patient will undergo sleep nasendoscopy as outlined below, in order to assess the involvement of the tongue base in the patient's sleep disordered breathing. This is a routine diagnostic procedure. Patients are pharmacologically induced into a light phase of sleep and the upper airway is visualized directly with a nasopharyngolaryngoscope. Anesthetic management will be performed in standard fashion, using propofol titrated to an endpoint of moderate sedation, as is typically done for procedural sedation in esophagogastroduodenoscopy. Administration will be logged to permit analysis of dosing requirements. Respiratory pattern will be monitored noninvasively and logged to permit correlation of obstruction to propofol administration.
Visit 3 - Intraoperative Setting. The patient will undergo an evaluation for "adequate exposure" for transoral robotic surgery and if "adequate exposure" is achieved then they will undergo transoral robotic surgery for lingual tonsillar hypertrophy to treat obstructive sleep apnea.
Visit 4 - Postoperative Setting. This will be in the inpatient and/or outpatient setting within three weeks of surgical procedure. The patient will undergo routine postoperative clinical evaluation.
Visit 5 - Postoperative Testing. The patient will undergo a follow-up sleep study to determine efficacy of the surgical procedure at three months post-operatively, the standard interval used to determine the outcome of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral robotic surgery (TORS) | Experimental | Procedure: Transoral robotic surgery (TORS)da Vinci® Robotic Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Pre-operative exclusion criteria:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral robotic surgery (TORS)Also: da Vinci® Robotic Surgical SystemThe 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. | Procedure or surgery | Transoral robotic surgery (TORS) |
Primary outcome
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.
Time frame: 1 year
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Thaler, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral robotic surgery (TORS) in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.