Fuzzle System for Appetite Control and Weight Management

Part of paid clinical trials in Bradenton, Florida.

Sponsor
Fuzzle Operating Co.
Study ID
NCT07527559
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Fuzzle Intraoral Device — DEVICE
    The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear as an adjunct to weight management. The device is created from dental impressions to ensure a patient-specific fit. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene. The device is intended to modulate oral sensory input within the stomatognathic system, with the goal of influencing eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. It is non-invasive, reversible, and used in a home setting under provider supervision.
  • Lifestyle Management — BEHAVIORAL
    Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.

Study Details

This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling. Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day. The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period. Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group not to receive Fuzzle intraoral device.
    Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.
  • Experimental: Investigational group to receive Fuzzle intraoral device
    Participants receive the Fuzzle intraoral device in addition to standardized lifestyle management as described in the control arm. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene.

Primary Outcome Measure

Percent Total Body Weight Loss (%TBWL) at 16 Weeks [ Time Frame: From study enrollment to completion at 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
DM Clinical ResearchBradentonFlorida34209-

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By research site
DM Clinical Research· Bradenton, FL

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