Fuzzle System for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jeremy McConnell, MD
Principal Investigator
Dynamed Clinical Research
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Fuzzle intraoral device and/or standardized lifestyle counseling for weight management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fuzzle System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fuzzle Operating Co.
Lead Sponsor
Dynamed Clinical Research
Collaborator
Advarra
Industry Sponsor
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