Trial Outcomes & Findings for Clinical Feasibility of New Tracheoesophageal Puncture Set (NCT NCT01045057)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

immediate observation during surgery

Results posted on

2021-06-11

Participant Flow

Prospective study, carried out in 5 different medical centers in 4 different countries. Recruitment period runs from November 2009-March 2011

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Feasibility of New Tracheoesophageal Puncture Set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provox Vega Puncture Set n=27 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants
Region of Enrollment Belgium	7 participants n=5 Participants
Region of Enrollment Germany	13 participants n=5 Participants
Region of Enrollment Netherlands	5 participants n=5 Participants

PRIMARY outcome

Timeframe: immediate observation during surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Provox Vega Puncture Set n=27 Participants 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
Success Rate of Procedure	23 Nr part. with succesful insertions

SECONDARY outcome

Timeframe: 1 month

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Provox Vega Puncture Set n=27 Participants 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
Satisfaction of Physician	26 Number of times new set was preferred

SECONDARY outcome

Timeframe: 1 month

Population: 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.

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

Outcome measures

Outcome measures
Measure	Provox Vega Puncture Set n=27 Participants 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
Cost Effectiveness Calculation	155.4 seconds Standard Deviation 115.6

SECONDARY outcome

Timeframe: 1 month

Population: 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.

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

Outcome measures

Outcome measures
Measure	Provox Vega Puncture Set n=6 Participants 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
Postoperative Results Satisfisfied with procedure	6 Number of patients
Postoperative Results Would recommend procedure	6 Number of patients

Adverse Events

Provox Vega Puncture Set

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Provox Vega Puncture Set n=27 participants at risk 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
Surgical and medical procedures Pharyngocutaneous Fistula	11.1% 3/27 • Number of events 3 • During one month after the surgery all adverse events, including expected/non-related events were recorded
Surgical and medical procedures Damage posterior pharyngeal wall	3.7% 1/27 • Number of events 1 • During one month after the surgery all adverse events, including expected/non-related events were recorded
Surgical and medical procedures Damage posterior esophageal wall	3.7% 1/27 • Number of events 1 • During one month after the surgery all adverse events, including expected/non-related events were recorded
Surgical and medical procedures Retracted voice prosthesis	3.7% 1/27 • Number of events 1 • During one month after the surgery all adverse events, including expected/non-related events were recorded
Surgical and medical procedures Tracheitis	3.7% 1/27 • Number of events 1 • During one month after the surgery all adverse events, including expected/non-related events were recorded
Surgical and medical procedures Wound dehiscence	3.7% 1/27 • Number of events 1 • During one month after the surgery all adverse events, including expected/non-related events were recorded

Additional Information

Director of Clinical Affairs

Atos Medical AB

Phone: +1 352 870 0872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place