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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Puncture Set and Flexible Protector | Experimental | Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puncture Set and Flexible Protector | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Procedure | 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. | immediate observation during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of Physician | 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. | 1 month |
| Cost Effectiveness Calculation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frans JM Hilgers, MD, PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | 3000 | Belgium | |||
| Bundeswehr Krankenhaus |
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Prospective study, carried out in 5 different medical centers in 4 different countries. Recruitment period runs from November 2009-March 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Provox Vega Puncture Set | Patients with laryngeal cancer and a total laryngectomy in whom a puncture was made and a voice prosthesis was placed by means of the Provox Vega Puncture Set |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Provox Vega Puncture Set | Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate of Procedure | 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. | Posted | Number | Nr part. with succesful insertions | immediate observation during surgery |
|
During one month after the surgery
all adverse events, including expected/non-related events were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Provox Vega Puncture Set | Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngocutaneous Fistula | Surgical and medical procedures | Non-systematic Assessment | In all 3 patients known significant risk factors were present that are deemed to have caused the fistula. As such, these complications are not considered related to device/procedure. Fistula occurrence rate was within previously reported ranges. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Atos Medical AB | +1 352 870 0872 | Corina.van.As@atosmedical.com |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Provox Vega Puncture Set
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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
| 1 month |
| Postoperative Results | Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire. | 1 month |
| Ulm |
| 89081 |
| Germany |
| Netherlands Cancer Institute | Amsterdam | North Holland | 1066 CX | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3015GD | Netherlands |
| Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona | Barcelona | 08025 | Spain |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Satisfaction of Physician | 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. | Posted | Number | Number of times new set was preferred | 1 month |
|
|
|
| Secondary | Cost Effectiveness Calculation | 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. | Posted | Mean | Standard Deviation | seconds | 1 month |
|
|
|
| Secondary | Postoperative Results | 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. | Posted | Number | Number of patients | 1 month |
|
|
|
| 0 |
| 27 |
| 8 |
| 27 |
|
| Damage posterior pharyngeal wall | Surgical and medical procedures | Non-systematic Assessment | Posterior pharyngeal wall was damaged during dilatation before the puncture took place. Non-device related. |
|
| Damage posterior esophageal wall | Surgical and medical procedures | Non-systematic Assessment | Puncture penetrated posterior esophageal wall because window of device used for pharynx protection (not part of subject device)could not be located by palpation or visualization. Event did not cause any harm to patient. Event is not device related. |
|
| Retracted voice prosthesis | Surgical and medical procedures | Non-systematic Assessment | Voice prosthesis retracted while cleaning it, and was repositioned. No patient harm. Event is related to patient anatomy, not related to device/procedure.Occurred in home situation, can occur when voice prosthesis (e.g. due to edema) fits too tight. |
|
| Tracheitis | Surgical and medical procedures | Non-systematic Assessment | Patient developed tracheitis, caused by COPD and the related use of Prednisone and inhalation medications. Patient received antibiotics and was fine. Event was unrelated to device. |
|
| Wound dehiscence | Surgical and medical procedures | Non-systematic Assessment | Wound healing problems considered to be caused by pre-existing risk factors (Radiotherapy,prednisone use)and surgical risk factor of bilateral neck dissection.Not device related. |
|
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| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |