Overweight and Obesity Clinical Trial
Official title:
A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4).
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27.
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Subjects will be studied in an open label study that will have one endpoint at 20 weeks. Up to 20 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. The initial diet will be liquid and will be advanced as per the dietician's recommendations. Changes in diet will depend on subject tolerance to the balloon and specific food intolerances and will be adjusted frequently by the dietician. The initial balloon volume will be 450 to 550 ml of 0.9% normal saline with 2 ml of a 1% solution of methylene blue. It is estimated, based on clinical studies, that approximately 10% of subjects will be intolerant in the first month and will require a down adjustment, wherein 150 ml of fluid will be removed from the balloon. An up adjustment will be performed at 16 weeks (±2 weeks) with the addition of 200-300 ml of 0.9% normal saline, as per section 1.7.2.1.3.3. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. The subjects will be followed for 2 weeks after the up-adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
| Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
| Completed |
NCT03602001 -
Attentive Eating for Weight Loss
|
N/A | |
| Recruiting |
NCT06269159 -
The Power of 24-hour: Co-designing Intervention Components
|
||
| Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
| Completed |
NCT02996864 -
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
|
N/A | |
| Completed |
NCT04647149 -
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
|
N/A | |
| Terminated |
NCT03914066 -
A Group-based Treatment of Overweight and Obesity in Primary Care
|
N/A | |
| Completed |
NCT03685656 -
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
|
N/A | |
| Completed |
NCT05051579 -
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
|
Phase 2 | |
| Completed |
NCT04611477 -
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
|
N/A | |
| Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
| Completed |
NCT03599115 -
Effects of Inhibitory Control Training in Eating Behaviors
|
N/A | |
| Recruiting |
NCT05938894 -
Train Your Brain - Executive Function
|
N/A | |
| Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
| Recruiting |
NCT05987306 -
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
|
N/A | |
| Completed |
NCT03792685 -
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
|
N/A | |
| Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
| Completed |
NCT04520256 -
Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
|
Phase 2/Phase 3 | |
| Completed |
NCT04979234 -
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
|
N/A |