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Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study
Evaluate the safety and efficacy of the Zelegent, Inc. Elevoâ„¢ Kit Snoring Intervention Device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis.
The Zelegent, Inc. Elevoâ„¢ Kit Snoring Intervention Device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevoplasty treatment | Other | Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevoplasty | Device | The Elevoâ„¢ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevoâ„¢ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device ("Elevo Kit") to Snoring Visual Analog Scale post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device ("Elevo Kit") (2) Snoring Visual Analog Scale (VAS) post-intervention with the device ("Elevo Kit"). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry "Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring." A numeric "0" response corresponds to "Light Loudness". A numeric "5" response corresponds to "Moderate Loudness". A numeric "10" response corresponds to "Intense Loudness". | Thirty (30) days post device intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device ("Elevo Kit") to Snoring Visual Analog Scale post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device ("Elevo Kit") (2) Snoring Visual Analog Scale (VAS) post-intervention with the device ("Elevo Kit"). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry "Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring." A numeric "0" response corresponds to "Light Loudness". A numeric "5" response corresponds to "Moderate Loudness". A numeric "10" response corresponds to "Intense Loudness". |
| Measure | Description | Time Frame |
|---|---|---|
| Mean within-subject change in SNAP Diagnostics Home Sleep Study (HSS) Measure #1 from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) Percent (%) of snoring events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) pre-treatment (2) Percent (%) of snoring events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) post-treatment. Key to Snoring Event Types (as categorized by SNAP Diagnostics, Inc.) Type I: Mostly Palate Type II: Mostly Palate + tongue Type III: Sound, but no particular pattern, can originate from lungs or from upper airway Type IV: High pitch, more diffuse, similar to asthma Type WL: Wheezing-like. Resulting value of Measure #1 is in percents (%). Note: Measure #1 will be repeated via Home Sleep Study at Day 90 post-treatment and will be repeated via Home Sleep Study at Day 180 post-treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Catalano, MD | St. Elizabeth's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Entrust Medical Group | Orange | California | 92868 | United States | ||
| ChicagoENT (*Note: it's important to capitalize the "ENT") |
IPD will remain confidential to the Investigators and to the Sponsor
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study
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| Ninety (90) days post device intervention |
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device ("Elevo Kit") to Snoring Visual Analog Scale post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device ("Elevo Kit") (2) Snoring Visual Analog Scale (VAS) post-intervention with the device ("Elevo Kit"). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry "Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring." A numeric "0" response corresponds to "Light Loudness". A numeric "5" response corresponds to "Moderate Loudness". A numeric "10" response corresponds to "Intense Loudness". | One hundred eighty (180) days post device intervention |
| Thirty (30) days post device intervention |
| Mean within-subject change in SNAP Diagnostics Home Sleep Study (HSS) Measure #2 from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) Average loudness ratio (loudness is measured in decibels [dB]) of events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) pre-treatment (2) Average loudness ratio of events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) post-treatment. Key to Snoring Event Types (as categorized by SNAP Diagnostics, Inc.) Type I: Mostly Palate Type II: Mostly Palate + tongue Type III: Sound, but no particular pattern, can originate from lungs or from upper airway Type IV: High pitch, more diffuse, similar to asthma Type WL: Wheezing-like. Resulting value of Measure #2 is an absolute number. Note: Measure #2 will be repeated via Home Sleep Study at Day 90 post-treatment and will be repeated via Home Sleep Study at Day 180 post-treatment. | Thirty (30) days post device intervention |
| Mean within-subject change of Pittsburgh Sleep Quality Index (PSQI) from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) PSQI Score pre-treatment (2) PSQI Score post-treatment. Resulting value is an absolute number. The PSQI is a self-report (i.e., patient-reported outcome) questionnaire that is comprised of nineteen (19) individual items that create seven (7) components that produce one (1) global score. The PSQI takes 5 - 10 minutes to complete. Note: the PSQI questionnaire will be repeat-administered at Day 90 post device intervention and will be repeat-administered at Day 180 post device intervention. | Thirty (30) days post device intervention |
| Mean within-subject change of Epworth Sleepiness Scale (ESS) from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit"). | Difference between the two following parameters: (1) ESS Score pre-treatment (2) ESS Score post-treatment. Resulting value is an absolute number. The ESS is a self-report (i.e., patient-reported outcome) scale that is intended to measure daytime sleepiness and that is measured by use of a very short questionnaire. Note: the ESS questionnaire will be repeat-administered at Day 90 post device intervention and will be repeat-administered at Day 180 post device intervention. | Thirty (30) days post device intervention |
| Chicago |
| Illinois |
| 60657 |
| United States |
| St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
| Park Avenue Sinus & Sleep Center | New York | New York | 10016 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |