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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01222871
Other study ID # 00540
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date July 2010
Est. completion date August 2012

Study information

Verified date June 2018
Source Steward St. Elizabeth's Medical Center of Boston, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.


Description:

nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date August 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- Patients with early nasal polyposis

Exclusion Criteria:

- Age < 18 years

- Patients with active sinus infections

- Patients on long term steroids

- Allergy or sensitivity to steroids

- Patients with Antrochoanal polyps

- Patients who received topical steroids by bio-resorbable sponge or oral steroids

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone
Triamcinolone soaked nasopore dressing
Saline soaked sponge
saline soaked sponge

Locations

Country Name City State
United States St. Elizabeth's Medical Center, 736 Cambridge St Brighton Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nasal Endoscopic Exam Findings . nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant. 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
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