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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05086302
Other study ID # Spatz3-PAS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 3, 2021
Est. completion date February 2025

Study information

Verified date January 2024
Source Spatz FGIA, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.


Description:

The purpose of the study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling. Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks. Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects will follow a 1000-1200 kcal/day-deficit diet during their participation in the study. At 18 weeks ±4 weeks, subjects will be evaluated, and those that meet the criteria will undergo an adjustment procedure wherein the balloon volume will be increased to achieve extra weight loss. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure. At the end of the 32-week treatment period, all subjects who lost at least 5% Total Body Weight Loss (TBWL) prior to device removal will be followed for an additional 6 months. In addition, patients with device- and/or procedure-related adverse events will be followed until resolution of the event


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 537
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 22 - 65 2. BMI = 35 and <40 kg/m2 or BMI of 30 to 34.9 kg/m2 with one or more major obesity- related comorbid conditions 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure 4. History of obesity (BMI = 30) for at least 2 years 5. History of failure with non-surgical weight loss methods 6. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling 7. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits 8. Ability to give informed consent 9. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician. Exclusion Criteria: 1. Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery. 2. Prior open or laparoscopic bariatric surgery. 3. Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery. 4. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease 5. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 6. A gastric mass. 7. A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms. 8. Acid reflux symptoms to any degree that require more than one medication for symptom control. 9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope. 10. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device 11. Severe coagulopathy. 12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months. 13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy 14. Chronic abdominal pain 15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation 16. Hepatic insufficiency or cirrhosis 17. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months. 18. Alcoholism or drug addiction. 19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up. 20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants. 21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant. 22. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system. 23. Patients who have BOTH: 1. A previous history of a serotonin syndrome AND 2. currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)]. 24. Patients who are pregnant or breast-feeding. 25. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs 26. Subjects who have tested positive for H. Pylori, and who have not yet been treated. 27. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications 28. Subjects who are taking corticosteroids, immunosuppressants, and narcotics 29. Subjects who are taking diet pills 30. Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach. 31. Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings. 32. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. 33. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer. 34. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised. 35. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile. 36. Specific diagnosed genetic or hormonal cause for obesity such as untreated hypothyroidism or Prader Willi syndrome 37. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating 38. Known history of endocrine disorders affecting weight

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Puerto Rico FRC Gastro Bayamon
Puerto Rico GI Offices of Dr. Rodriguez and Dr. Osorio Bayamon
United States True You Weight Loss (Atlanta) Atlanta Georgia
United States True You Weight Loss Cary North Carolina
United States JourneyLite Physicians Cincinnati Ohio
United States Gastro Center of Maryland Columbia Maryland
United States The Silhouette Clinic Germantown Maryland
United States JSAPA Jupiter Florida
United States Atlantic Medical Group Kinston North Carolina
United States Reveal Weight Loss Livingston New Jersey
United States Weight Loss and Wellness Center Livingston New Jersey
United States Carson D Liu MD Medical Corp Marina Del Rey California
United States Basin Surgical Midland Texas
United States Steven Batash, M.D., P.C. New York New York
United States NRHS Journey Clinic Norman Oklahoma
United States Endoscopic Wellness Center of America Reston Virginia
United States Mayo Clinic Rochester Minnesota
United States Transform Weight Loss Seattle Washington
United States New Jersey Bariatric Center Springfield New Jersey
United States Formation Tampa Florida
United States Advanced Gastroenterology & Hepatology of Greater Washington Vienna Virginia
United States New York Bariatric Group - Wayne Location Wayne New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Spatz FGIA, Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serious Adverse Events (SAEs) The primary study endpoint is to demonstrate that the rate of device or procedure related SAEs is less than 8% at 8 months 32 weeks
Secondary Percentage of Total Body Weight Loss (%TBWL) The secondary study endpoint is to demonstrate that the mean percent TBL in the effectiveness cohort is not less than 11% at 32 weeks. 32 weeks
Secondary Mean %TBL and percent excess weight loss (EWL%) Mean %TBL and percent excess weight loss (EWL %) at 56 weeks in subjects who lost at least 5% TBL at 32 weeks 56 weeks
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