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← Laryngeal Cancer

NCT01045057 · STUDY IN CONTEXT

Clinical Feasibility of New Tracheoesophageal Puncture Set

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. 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.

primary · POSTED

As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.

Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.

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secondary · POSTED

Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.

Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.

→

secondary · POSTED

cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure

Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.

→

secondary · POSTED

Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.

Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.

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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-laryngeal-cancer
nct id
NCT01045057
trial label
Clinical Feasibility of New Tracheoesophageal Puncture Set
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.
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-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0000
    source section id
    NCT01045057-om-0000
    source outcome index
    0
    endpoint
    Success Rate of Procedure
    endpoint definition
    As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
    time origin
    immediate observation during surgery
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
    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-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0001
    source section id
    NCT01045057-om-0001
    source outcome index
    1
    endpoint
    Satisfaction of Physician
    endpoint definition
    Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.
    time origin
    1 month
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
    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-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0002
    source section id
    NCT01045057-om-0002
    source outcome index
    2
    endpoint
    Cost Effectiveness Calculation
    endpoint definition
    cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure
    time origin
    1 month
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.
    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-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0003
    source section id
    NCT01045057-om-0003
    source outcome index
    3
    endpoint
    Postoperative Results
    endpoint definition
    Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
    time origin
    1 month
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.
    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-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Provox Vega Puncture Set
    regimen
    Patients with laryngeal cancer and a total laryngectomy in whom a TE puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01045057-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Provox Vega Puncture Set
    regimen
    Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01045057-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Provox Vega Puncture Set
    regimen
    Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
    analyzed count
    27
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01045057-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT01045057
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Secondary Puncture
    regimen
    Patients who had a secondary puncture
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01045057-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT01045057
    harm key
    EG000
    source section id
    NCT01045057-ae
    event group key
    EG000
    event group label
    Provox Vega Puncture Set
    serious affected
    0
    serious at risk
    27
    other affected
    8
    other at risk
    27
    frequency threshold
    0
    collection period
    During one month after the surgery
    event definition
    all adverse events, including expected/non-related events were recorded
    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