NCT01541839

Brief Summary

The primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty. The secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

January 10, 2023

Completed
Last Updated

January 11, 2023

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

February 24, 2012

Results QC Date

March 11, 2013

Last Update Submit

January 9, 2023

Conditions

Nasal Obstruction

Keywords

Nasal septumNasal surgical procedures

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    The primary outomce of this study is to determine if time is saved in the operating room by using the septal stapler instead of suture.

    1 day

Secondary Outcomes (2)

  • Subjective Function

    up to 2 months

  • Post-operative Complications

    3 weeks

Study Arms (2)

Septal Stapler

EXPERIMENTAL

This group will have closure of their nasal septal flaps via septal stapler.

Device: Septal Stapler

Control (Suture)

NO INTERVENTION

This arm will have closure of their nasal septal flaps as routinely performed with suture passed in a quilting fashion.

Interventions

Septal StaplerDEVICE

This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.

Also known as: ENTact Septal Stapler (ENTrigue surgical 601-00100)
Septal Stapler

Eligibility Criteria

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

You may qualify if:

  • primary septoplasty
  • age\>18
  • septal deviation
  • ability to read and communicate in English
  • absence of allergic rhinitis
  • non-smoker

You may not qualify if:

  • revision septoplasty
  • age \<18
  • concurrent sinusitis or endoscopic sinus surgery
  • existing nasal septal perforation
  • smoker
  • diabetes mellitus
  • allergy to polylactide-co-glycolide (PLG)
  • non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (2)

  • Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.

    PMID: 14990910BACKGROUND

  • Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.

    PMID: 15054368BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Limitations and Caveats

Limited by potential bias of surgeon (not blinded to closure method).

Results Point of Contact

Title
Dr. Erin Wright
Organization
University of Alberta
erin.wright@me.com
780-407-7656

Study Officials

  • Erin D Wright, MDCM, FRCSC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 1, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

January 11, 2023

Results First Posted

January 10, 2023

Record last verified: 2022-11

Locations

CA(1)