Otorhinolaryngologic DiseasesNCT01669278
Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy
A study testing Endosheath in people with Otorhinolaryngologic Diseases, run by University of Alberta at 1 site in Canada.
Trial summary
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Otorhinolaryngologic Diseases
- What is being tested?
- Endosheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy
Who cannot join
- Known sinonasal masses or nasal polyposis
- Unable to complete VAS surveys
- Significant septal deviation
- Unable to tolerate in-office flexible nasopharyngoscopy
- Patients who refuse consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.
Read the detailed description
Methods: Randomized, single-blinded, controlled trial
Setting: Office practice of two academic otolaryngologists at a community hospital.
Primary Outcomes: Patient pain and discomfort, Optical quality
Secondary Outcomes: Physician and nursing staff satisfaction
Cost-analysis
Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy
- Conditions
- Otorhinolaryngologic Diseases
- Being tested
- Endosheath
- Keywords
- sheath, flexible, endoscopy, otolaryngology, office
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndosheathDevice
Flexible sheathed nasopharyngolaryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Traditional flexible nasopharyngolaryngoscopy | No intervention | No sheath procedure |
| Sheath flexible nasopharyngolaryngoscopy | Active comparator | Flexible nasopharyngolaryngoscopy using endosheath Receives: Device: Endosheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain and discomfort
Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale
Measured: 1 hour
Secondary outcomes (2)
Physician and staff satisfaction
Physician and support staff satisfaction with easy and efficiency of sheathed scopes.
Measured: 1 week
Optical quality
Image quality of flexible endoscopy with or without endosheath.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Allan Ho, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669278
- Sponsor's protocol ID
- UA-Endo001
- Status last verified
- Sep 2016
- First submitted
- 7 Aug 2012
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01669278
- Acronym / sponsor ID
- UA-Endo001
- Conditions
- Otorhinolaryngologic Diseases
- Keywords
- sheath, flexible, endoscopy, otolaryngology, office
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.
Detailed description
Methods: Randomized, single-blinded, controlled trial
Setting: Office practice of two academic otolaryngologists at a community hospital.
Primary Outcomes: Patient pain and discomfort, Optical quality
Secondary Outcomes: Physician and nursing staff satisfaction
Cost-analysis
Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional flexible nasopharyngolaryngoscopy | No intervention | –No sheath procedure |
| Sheath flexible nasopharyngolaryngoscopy | Active comparator | Device: EndosheathFlexible nasopharyngolaryngoscopy using endosheath |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy
Key exclusion criteria (5 listed)
- Known sinonasal masses or nasal polyposis
- Unable to complete VAS surveys
- Significant septal deviation
- Unable to tolerate in-office flexible nasopharyngoscopy
- Patients who refuse consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndosheathFlexible sheathed nasopharyngolaryngoscopy | Device | Sheath flexible nasopharyngolaryngoscopy |
Primary outcome
Patient pain and discomfort
Time frame: 1 hour
Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale
2 secondary outcomes
Physician and staff satisfaction
Time frame: 1 week
Optical quality
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Allan Ho principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endosheath in people with Otorhinolaryngologic Diseases, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient pain and discomfort (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.