An interventional study of Puncture Set and Flexible Protector in Larynx Cancer, sponsored by Atos Medical AB. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Atos Medical AB · Not applicable, Interventional, and Treatment
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.
244 studies on the registry are indexed under Laryngeal Neoplasms; 63 are open to participants now.
This study's enrollment of 27 is below the median of 44 across 181 interventional studies indexed under Laryngeal Neoplasms.
Browse Laryngeal Neoplasms studies →Atos Medical AB is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
Device: Puncture Set and Flexible Protector
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.
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.
Time frame: immediate observation during surgery
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.
Time frame: 1 month
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
Time frame: 1 month
Postoperative Results
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Time frame: 1 month
Prospective study, carried out in 5 different medical centers in 4 different countries. Recruitment period runs from November 2009-March 2011
| Milestone | Provox Vega Puncture Set |
|---|---|
| Started | 27 |
| Completed | 27 |
| Not completed | 0 |
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.
| Nr part. with succesful insertions | Provox Vega Puncture Set |
|---|---|
| Success Rate of Procedure | 23 |
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 of times new set was preferred | Provox Vega Puncture Set |
|---|---|
| Satisfaction of Physician | 26 |
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
| seconds | Provox Vega Puncture Set |
|---|---|
| Cost Effectiveness Calculation | 155.4 ± 115.6 |
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
| Number of patients | Secondary Puncture |
|---|---|
| Satisfisfied with procedure | 6 |
| Would recommend procedure | 6 |
Collected over During one month after the surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Provox Vega Puncture Set | — | 0/27 (0%) | 8/27 (29.6%) |
| Event | Provox Vega Puncture Set |
|---|---|
| Pharyngocutaneous FistulaSurgical and medical procedures | 3/27 |
| Damage posterior pharyngeal wallSurgical and medical procedures | 1/27 |
| Damage posterior esophageal wallSurgical and medical procedures | 1/27 |
| Retracted voice prosthesisSurgical and medical procedures | 1/27 |
| TracheitisSurgical and medical procedures | 1/27 |
| Wound dehiscenceSurgical and medical procedures | 1/27 |
| Age, Categorical(Participants) | Provox Vega Puncture Set |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 9 |
| Age, Continuous(years) | Provox Vega Puncture Set |
|---|---|
| Mean | 62 ± 7.8 |
| Sex: Female, Male(Participants) | Provox Vega Puncture Set |
|---|---|
| Female | 4 |
| Male | 23 |
| Region of Enrollment(participants) | Provox Vega Puncture Set |
|---|---|
| Spain | 2 |
| Belgium | 7 |
| Germany | 13 |
| Netherlands | 5 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Atos Medical AB