Clinical trial

Fuzzle System for Appetite Control and Weight Management

Opening soon · Not applicable · 1 countries · Registry ID NCT07527559

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

Inclusion Criteria: * Adults aged 18-65 years * Body mass index (BMI) ≥30 kg/m² at screening * Willing and able to provide informed consent * Willing to comply with study visits and procedures * Willing to participate in standardized lifestyle counseling Exclusion Criteria: * Participation in another weight-loss clinical study within 90 days * Pregnancy, breastfeeding, or intent to become pregnant during the study period * History of eating disorders or uncontrolled psychiatric illness * Oral or dental conditions preventing safe device use * Current use of prescription or over-the-counter weight-loss medications * A1C \>8.0% at screening (glycemic subset exclusion only) * Unstable diabetes medication regimen (glycemic subset exclusion only) * Any medical condition that, in the investigator's judgment, would interfere with safe participation

Treatments and study arms

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.

Primary outcomes

Percent Total Body Weight Loss (%TBWL) at 16 WeeksFrom study enrollment to completion at 16 weeks

Percent total body weight loss (%TBWL) will be compared between study arms at Week 16. %TBWL is calculated as \[(baseline body weight - Week 16 body weight) ÷ baseline body weight\] × 100, where higher values indicate greater weight loss. Body weight will be measured using standardized procedures during in-person clinic visits.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

DM Clinical Research🇺🇸 Bradenton, Florida, United States

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