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not enough particpants
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone | Experimental | Triamcinolone soaked nasopore dressing |
|
| Control Group | Placebo Comparator | Saline soaked sponge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Triamcinolone soaked nasopore dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Catalano, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth's Medical Center, 736 Cambridge St | Brighton | Massachusetts | 02135 | United States |
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One subject enrolled but study was terminated and subject did not start the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triamcinolone | Nasopore Triamcinolone soaked sponge |
| FG001 | Control | Saline soaked sponge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
0
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| ID | Title | Description |
|---|---|---|
| BG000 | Triamcinolone | Nasopore Triamcinolone soaked sponge |
| BG001 | Control | Saline Soaked sponge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | No participant started because study was terminated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nasal Endoscopic Exam Findings . | nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant. | No participant started because study was terminated. | Posted | 2 weeks, 6 weeks, 12 weeks were not collected from any participant. |
|
|
no data collected, Study terminated.
No data collected, study terminated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triamcinolone | Nasopore Triamcinolone soaked sponge | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter catalano | SEMC | 1-617-789-5004 | peter.catalano@steward.org |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Patients will be randomized into 2 study groups, experimental and control.
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| Saline soaked sponge | Drug | saline soaked sponge |
|
| BG002 |
| Total |
Total of all reporting groups |
|
| Sex: Female, Male | No participant started because study was terminated. |
|
| Counts |
|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Saline Soaked Sponge | Nasopore saline soaked sponge | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control | Saline soaked sponge | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |