Fuzzle System for Appetite Control and Weight Management
A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "A subset of participants will provide blood samples for exploratory metabolic markers, including HbA1c, hsCRP, and ALT."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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
Study sites (1)
FL
- DM Clinical Research · Bradenton, FL 34209More trials in Bradenton