NCT00942903

Brief Summary

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 30, 2010

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

Enrollment Period

1 month

First QC Date

July 20, 2009

Results QC Date

August 4, 2010

Last Update Submit

October 13, 2010

Conditions

Total Laryngectomy

Keywords

HMEProvoxvoice prosthesislaryngectomy

Outcome Measures

Primary Outcomes (1)

  • Patient Preference for Provox HME or Provox XtraHME

    the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.

    3 weeks

Secondary Outcomes (1)

  • Noise at Stoma Occlusion

    3 weeks

Study Arms (1)

Compliant HME users

EXPERIMENTAL

Laryngectomized patients who are currently compliant (24/7) users of a Provox HME

Device: Provox Xtra HME

Interventions

Provox Xtra HMEDEVICE

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Also known as: Heat and Moisture Exchanger, Provox HME
Compliant HME users

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • total laryngectomy
  • compliant Provox HME user (24/7 use)

You may not qualify if:

  • current medical problems that might influence HME use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Results Point of Contact

Title
Prof. Dr. F.J.M. Hilgers
Organization
The Netherlands Cancer Institute
f.hilgers@nki.nl
+31-20-5122550

Study Officials

  • Frans JM Hilgers, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 22, 2010

Results First Posted

August 30, 2010

Record last verified: 2010-10

Locations

NL(1)