Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

NCT03083106 | Completed DMC FDA Device

• 1 other identifier: GCP002-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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").

  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").

  One hundred eighty (180) days post device intervention

Other Outcomes (4)

• 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").

  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").

  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").

  Thirty (30) days post device intervention

Study Arms (1)

Elevoplasty treatment

OTHER

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective

Device: Elevoplasty

Interventions

Elevoplasty DEVICE

The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ 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.

Elevoplasty treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 22 years (no maximum age)
• Has consistent Bed/Sleep Partner willing to provide Co-Participant Informed Consent
• Apnea Hypopnea Index (AHI) of \< 15 verified by polysomnogram (PSG) or by SNAP® Diagnostics Home Sleep Study (HSS)
• Has basic computer literacy (e.g., email) and home internet access or smartphone
• Chronic, simple snoring (verified by Bed/Sleep Partner)
• No prior surgical treatment for snoring
• Bed/Sleep Partner willing and capable of providing Informed Consent

You may not qualify if:

• Age \< 22 years
• Has no consistent Bed/Sleep Partner
• Apnea Hypopnea Index (AHI) \> 15 indicative of Obstructive Sleep Apnea
• Intermittent or occasional snoring
• Body Mass Index (BMI) \> 32 kg/m2
• Modified Mallampati 3 or 4
• Tonsil Grade 3 or 4+
• Significant nasal obstruction
• Previous palatal surgery
• Current cigarette smoker
• Known history of coronary artery disease or stroke
• Chronic obstructive pulmonary disease (COPD)
• Diabetes (Type I or Type II) non-controlled by medical management
• Major depression or non-controlled psychiatric illness
• Drug or alcohol abuse

Sponsors & Collaborators

• Zelegent, Inc.: lead

Study Sites (6)

Entrust Medical Group

Orange, California, 92868, United States

Location

ChicagoENT (*Note: it's important to capitalize the "ENT")

Chicago, Illinois, 60657, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Park Avenue Sinus & Sleep Center

New York, New York, 10016, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter J. Catalano, MD

  St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 17, 2017
• Study Start: March 3, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 30, 2020

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)