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NCT00721539 · STUDY IN CONTEXT

Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer
nct id
NCT00721539
trial label
Assessing the da Vinci® Robotic Surgical System for Surgery of the Upper Aerodigestive Tract
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0000
    source section id
    NCT00721539-om-0000
    source outcome index
    0
    endpoint
    Overall Complication Rate (Intraoperative and Postoperative)
    endpoint definition
    Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.
    time origin
    Six weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Subjects enrolled in this pilot study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0001
    source section id
    NCT00721539-om-0001
    source outcome index
    1
    endpoint
    Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure
    endpoint definition
    Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure
    time origin
    Six weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Adult patients 18 years of age and over
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0002
    source section id
    NCT00721539-om-0002
    source outcome index
    2
    endpoint
    Average Blood Loss
    endpoint definition
    Blood lost during procedure
    time origin
    Duration of procedure up to two hours
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0003
    source section id
    NCT00721539-om-0003
    source outcome index
    3
    endpoint
    Average Operative Time
    endpoint definition
    Average operative time in minutes
    time origin
    Up to four hours (240 minutes)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Transoral Robotic Surgery
    regimen
    Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00721539-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Transoral Robotic Surgery
    regimen
    Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00721539-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Transoral Robotic Surgery
    regimen
    Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00721539-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Transoral Robotic Surgery
    regimen
    Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract. da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth. Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00721539-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer
    nct id
    NCT00721539
    harm key
    EG000
    source section id
    NCT00721539-ae
    event group key
    EG000
    event group label
    Transoral Robotic Surgery
    serious affected
    0
    serious at risk
    9
    other affected
    0
    other at risk
    9
    frequency threshold
    0
    collection period
    Six weeks from the surgical date for each subject
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice