NCT02502084

Brief Summary

3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

July 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

July 13, 2015

Last Update Submit

December 20, 2017

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Safety assessed by unanticipated device-related adverse events

    During hospital stay, up to 1 day

Secondary Outcomes (1)

  • Performance assessed by anatomical landmarks reached and visualized will be recorded

    During procedure, up to 3 hours

Study Arms (1)

3NT flexible endoscope

EXPERIMENTAL

Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy

Device: 3NT flexible endoscope

Interventions

3NT flexible endoscopeDEVICE

The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.

Also known as: Sinusway
3NT flexible endoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
  • Patient age: adult (\>18 years old)
  • Patients in general good health in the opinion of the investigator as determined by medical history physical examination
  • A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent

You may not qualify if:

  • A patient with nasal polyposis
  • A patient indicated for tumor excision
  • Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
  • Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
  • Pregnancy
  • Patients with previous FESS surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, 9000, Belgium

Location

Assuta Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 20, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-01

Locations

BE(1)IL(1)