ObesityORBERA365NCT06785233
Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365
A study testing Non-Adjustable Intragastric Balloon and ORBERA365 in people with Obesity and Obesity, Morbid, run by Kaiser Clinic and Hospital at 1 site in Brazil.
Trial summary
INTRODUCTION: Obesity is a critical health condition associated with high rates of morbidity and mortality. Conservative therapies such as dietary restriction, physical exercise, and pharmacological treatments have not prevented the rising incidence of obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- Non-Adjustable Intragastric Balloon and ORBERA365
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with a Body Mass Index (BMI) above 27 kg/m²,
- both sexes,
- aged 18 years or older,
- who consent to their participation by signing an Informed Consent Form and
- agree to the implantation of the Orbera365® balloon at Kaiser Clinic and the Faculty of Medicine of ABC (FMABC)/Hospital Mario Covas.
Who cannot join
- Relative or absolute contraindications for this procedure, such as hiatal hernia (> 3 cm),
- Los Angeles grade erosive esophagitis,
- peptic ulcer,
- prior gastric surgery,
- substance dependence (alcohol or illicit drugs),
- continuous anticoagulant or anti-inflammatory therapy, and those with
- positive urease test results until treatment is completed and evidence of resolution is provided or follow-up is lost.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manoel Galvão Neto contact
Brazil1 site, 1 recruiting
- Recruiting
Faculdade ABC
Santo André, São Paulo, 09060-870
Eduardo Grecco, +55 11 98162-0911, atendimento@eduardogrecco.com.br
About this study
Official title: Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)
INTRODUCTION: Obesity is a critical health condition associated with high rates of morbidity and mortality. Conservative therapies such as dietary restriction, physical exercise, and pharmacological treatments have not prevented the rising incidence of obesity. Bariatric surgery, while effective, is limited to a relatively small proportion of the global obese population due to its strict indications and the risk of early and late postoperative complications. To address this gap, bariatric endoscopy therapies have emerged, offering less invasive, reversible, repeatable, and more cost-effective treatment options. The introduction of the intragastric balloon (IGB) in the 1980s marked the development of a minimally invasive, non-surgical, and safe procedure with low complication rates. OBJECTIVE: To evaluate the weight loss efficacy in overweight and Class I obese patients through the implantation of a 12-month non-adjustable intragastric balloon. METHODS: This prospective study involved overweight patients (BMI > 27 kg/m²) undergoing intragastric balloon treatment and multidisciplinary follow-up at the Bariatric Endoscopy Clinic of the Faculty of Medicine of ABC (FMABC) over a 12-month period. EXPECTED RESULTS: Weight loss following intragastric balloon implantation and improvement in metabolic indices.
Read the detailed description
Research Objective: The primary objective of this research will be to evaluate weight loss in overweight or class I obesity patients following the implantation of the Orbera365® non-adjustable intragastric balloon. The secondary objective will be to correlate demographic, endoscopic, and laboratory data with the outcomes of this procedure.
Patients and Methods: Patients with BMI > 27 kg/m² or BMI between 30-35 kg/m², regardless of gender and ethnic background, will undergo Orbera365® intragastric balloon implantation. The procedures will be performed at the Endoscopy Service of Mario Covas Hospital in São Paulo, SP and Kaiser Clinic in São José do Rio Preto, SP. Data collection will be conducted at the same locations. Information will be obtained during outpatient follow-up, including demographic data (sex, age), clinical data (height, weight, metabolic comorbidities), and operative data (complications).
Procedure Preparation: All examinations will be performed following a minimum 8-hour fasting period. The procedure will be initiated with the patient in left lateral decubitus under general anesthesia administered by an anesthesiologist. The balloon will be implanted under direct visualization in the gastric fundus and filled with up to 600 mL of 0.9% saline solution and 2% methylene blue.
Post-Procedure Recovery: Following the procedure and anesthesia recovery, all patients will be discharged but only with an accompanying person. All patients will receive guidance and will maintain contact with a physician to report any adverse signs or symptoms. Follow-up will include weekly consultations during the first month and monthly consultations thereafter, totaling one year of monitoring.
Outcomes: Primary outcome: To confirm the efficacy of the Orbera365® intragastric balloon in the primary treatment of obesity through evaluation of total weight loss.
Secondary outcome: To evaluate the use of the intragastric balloon in relation to demographic data and its impact on metabolic comorbidities.
Statistical Analysis: Analysis will be performed using Minitab Statistical Software, including normality tests, comparisons between numerical variables (Student's t-test or Mann-Whitney) and categorical variables (Pearson's chi-square or Fisher's exact test), considering p < 0.05 as significant.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- Non-Adjustable Intragastric Balloon, ORBERA365
- Keywords
- obesity, Intragastric Balloon
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Adjustable Intragastric BalloonDevice
Weight Loss with a 12-Month Non-Adjustable Intragastric Balloon is More Effective Compared to a 6-Month Balloon.
ORBERA365Device
Also called Intragastric Balloon
endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon
| Study group | Role | What they receive |
|---|---|---|
| Intragastric Ballon | Experimental | Endoscopic placement of Orbera365® non-adjustable intragastric balloon under general anesthesia. Device filled with 600mL saline solution with methylene blue, remaining in situ for 12 months. Weekly follow-up in first month, then monthly visits including nutritional and psychological support. Removal performed under general anesthesia after 12-month period. Receives: Device: Non-Adjustable Intragastric Balloon; Device: ORBERA365 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbera365® intragastric balloon.
Weight loss following the implantation of the Orbera365® intragastric balloon.
Weight loss following the implantation of the Orbera365® intragastric balloon. Weight loss following the implantation of the Orbera365® intragastric balloon.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Luiiz Kaiser Junior, Study chair, Kaiser Clinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785233
- Sponsor's protocol ID
- ISR ORBERA365
- Acronym
- ORBERA365
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)
- ClinicalTrials.gov ID
- NCT06785233
- Acronym / sponsor ID
- ORBERA365 / ISR ORBERA365
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- obesity, Intragastric Balloon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaiser Clinic and HospitalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION: Obesity is a critical health condition associated with high rates of morbidity and mortality. Conservative therapies such as dietary restriction, physical exercise, and pharmacological treatments have not prevented the rising incidence of obesity. Bariatric surgery, while effective, is limited to a relatively small proportion of the global obese population due to its strict indications and the risk of early and late postoperative complications. To address this gap, bariatric endoscopy therapies have emerged, offering less invasive, reversible, repeatable, and more cost-effective treatment options. The introduction of the intragastric balloon (IGB) in the 1980s marked the development of a minimally invasive, non-surgical, and safe procedure with low complication rates. OBJECTIVE: To evaluate the weight loss efficacy in overweight and Class I obese patients through the implantation of a 12-month non-adjustable intragastric balloon. METHODS: This prospective study involved overweight patients (BMI > 27 kg/m²) undergoing intragastric balloon treatment and multidisciplinary follow-up at the Bariatric Endoscopy Clinic of the Faculty of Medicine of ABC (FMABC) over a 12-month period. EXPECTED RESULTS: Weight loss following intragastric balloon implantation and improvement in metabolic indices.
Detailed description
Research Objective: The primary objective of this research will be to evaluate weight loss in overweight or class I obesity patients following the implantation of the Orbera365® non-adjustable intragastric balloon. The secondary objective will be to correlate demographic, endoscopic, and laboratory data with the outcomes of this procedure.
Patients and Methods: Patients with BMI > 27 kg/m² or BMI between 30-35 kg/m², regardless of gender and ethnic background, will undergo Orbera365® intragastric balloon implantation. The procedures will be performed at the Endoscopy Service of Mario Covas Hospital in São Paulo, SP and Kaiser Clinic in São José do Rio Preto, SP. Data collection will be conducted at the same locations. Information will be obtained during outpatient follow-up, including demographic data (sex, age), clinical data (height, weight, metabolic comorbidities), and operative data (complications).
Procedure Preparation: All examinations will be performed following a minimum 8-hour fasting period. The procedure will be initiated with the patient in left lateral decubitus under general anesthesia administered by an anesthesiologist. The balloon will be implanted under direct visualization in the gastric fundus and filled with up to 600 mL of 0.9% saline solution and 2% methylene blue.
Post-Procedure Recovery: Following the procedure and anesthesia recovery, all patients will be discharged but only with an accompanying person. All patients will receive guidance and will maintain contact with a physician to report any adverse signs or symptoms. Follow-up will include weekly consultations during the first month and monthly consultations thereafter, totaling one year of monitoring.
Outcomes: Primary outcome: To confirm the efficacy of the Orbera365® intragastric balloon in the primary treatment of obesity through evaluation of total weight loss.
Secondary outcome: To evaluate the use of the intragastric balloon in relation to demographic data and its impact on metabolic comorbidities.
Statistical Analysis: Analysis will be performed using Minitab Statistical Software, including normality tests, comparisons between numerical variables (Student's t-test or Mann-Whitney) and categorical variables (Pearson's chi-square or Fisher's exact test), considering p < 0.05 as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon
| Arm | Type | Receives |
|---|---|---|
| Intragastric Ballon | Experimental | Device: Non-Adjustable Intragastric Balloon, Device: ORBERA365Endoscopic placement of Orbera365® non-adjustable intragastric balloon under general anesthesia. Device filled with 600mL saline solution with methylene blue, remaining in situ for 12 months. Weekly follow-up in first month, then monthly visits including nutritional and psychological support. Removal performed under general anesthesia after 12-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with a Body Mass Index (BMI) above 27 kg/m²,
- both sexes,
- aged 18 years or older,
- who consent to their participation by signing an Informed Consent Form and
- agree to the implantation of the Orbera365® balloon at Kaiser Clinic and the Faculty of Medicine of ABC (FMABC)/Hospital Mario Covas.
Key exclusion criteria (7 listed)
- Relative or absolute contraindications for this procedure, such as hiatal hernia (> 3 cm),
- Los Angeles grade erosive esophagitis,
- peptic ulcer,
- prior gastric surgery,
- substance dependence (alcohol or illicit drugs),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Adjustable Intragastric BalloonWeight Loss with a 12-Month Non-Adjustable Intragastric Balloon is More Effective Compared to a 6-Month Balloon. | Device | Intragastric Ballon |
| ORBERA365Also: Intragastric Balloonendoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon | Device | Intragastric Ballon |
Primary outcome
Orbera365® intragastric balloon.
Time frame: 12 weeks
Weight loss following the implantation of the Orbera365® intragastric balloon. Weight loss following the implantation of the Orbera365® intragastric balloon. Weight loss following the implantation of the Orbera365® intragastric balloon.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manoel Galvão Neto contact
Roberto Luiiz Kaiser Junior study chair
Kaiser Clinica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Adjustable Intragastric Balloon and ORBERA365 in people with Obesity and Obesity, Morbid, run by Kaiser Clinic and Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luiz Gustavo de Quadros LGQ Quadros, Doutor (+55 17 98138-8737, gustavo_quadros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbera365® intragastric balloon. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.