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NCT01045057 · REGISTRY CONDITION SEARCH

Clinical Feasibility of New Tracheoesophageal Puncture Set

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2021-06-11

During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Success Rate of Procedure

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outcome · POSTED

Satisfaction of Physician

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outcome · POSTED

Cost Effectiveness Calculation

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outcome · POSTED

Postoperative Results

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * primary puncture during total laryngectomy * secondary puncture some time after total laryngectomy Exclusion Criteria: * anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture * not eligible to use a voice prosthesis for other reasons
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
    intervention Names
    1. Device: Puncture Set and Flexible Protector
    label
    Puncture Set and Flexible Protector
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Puncture Set and Flexible Protector
    description
    The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.
    name
    Puncture Set and Flexible Protector
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
intervention Model Description
Provox Vega Puncture Set
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
27
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Success Rate of Procedure
    time Frame
    immediate observation during surgery
secondary Outcomes
  1. description
    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.
    measure
    Satisfaction of Physician
    time Frame
    1 month
  2. description
    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
    measure
    Cost Effectiveness Calculation
    time Frame
    1 month
  3. description
    Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
    measure
    Postoperative Results
    time Frame
    1 month
Full study description
brief Summary
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5018a3ba7ddfe437f26c
      requested nct id
      NCT01045057
      primary nct id
      NCT01045057
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      payload sha256
      d395e32377f5a9ecf280f6bc87eeb0d2b571f8608fc41f64ca60761c7d866193
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5018a3ba7ddfe437f26c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01045057
      occurrences
      1. context exact
        NCT01045057
        end
        11
        exact text
        NCT01045057
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
      source file sha256
      fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
      source json pointer
      /studies/19/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e72995fbcb0e134342d735871f12c262260742bcfd00bd09924e61bf14d70442

    Preserved source evidence · Not medical advice