ObesityNCT05514288
Benefits of Endoscopic Bariatric Procedures
A study testing Endobariatric procedure in people with Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Endobariatric procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are considering undergoing EBT for weight loss
- Patients with a BMI >30 kg/m2 (without obesity related comorbidities)
- Patients with a BMI >27 kg/m2 (with obesity related comorbidities)
- Patients willing and able to comply with study requirements for follow-up
- Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
- Individuals 18 years old or older are included
Who cannot join
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
Show all 10Show fewer
- Pregnant or planning to become pregnant during period of study participation
- Patient refuses or is unable to provide written informed consent
- Prior surgical or endoscopic anti-reflux procedure
- Patients who are unwilling or unable to comply with the follow-up study schedule
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Liliana Bancila
Los Angeles, California, 90048
Liliana Bancila
Kenneth H Park, MD
About this study
Official title: Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
Read the detailed description
The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.
The primary research procedures are:
- EBT procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe])
- Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
- Collection of blood to evaluate changes in hormonal profiles
- Conditions
- Obesity
- Being tested
- Endobariatric procedure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobariatric procedureProcedure or surgery
Endoscopic sleeve gastroplasty or transoral outlet reduction
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty/Transoral outlet reduction | Other | Not described Receives: Procedure: Endobariatric procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight after various endoscopic bariatric therapies
The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.
Measured: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure
Secondary outcomes (1)
Changes in hormonal profiles after various endoscopic bariatric therapies
Repeated blood draws will be performed, and the following hormones will be measured: ghrelin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), gastric inhibitory polypeptide (GIP), and oxyntomodulin. We will compare changes over time in hormonal levels after EBT to baseline, 3 months, and 6 months post-procedure.
Measured: Baseline/pre-procedure, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Nov 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Park, Cedars-Sinai Medical Center
- Investigators
- Kenneth Park, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514288
- Sponsor's protocol ID
- STUDY00002145
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
- ClinicalTrials.gov ID
- NCT05514288
- Acronym / sponsor ID
- STUDY00002145
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Aug 2022 (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.
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
Detailed description
The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.
The primary research procedures are:
- EBT procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe])
- Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
- Collection of blood to evaluate changes in hormonal profiles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty/Transoral outlet reduction | Other | Procedure: Endobariatric procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are considering undergoing EBT for weight loss
- Patients with a BMI >30 kg/m2 (without obesity related comorbidities)
- Patients with a BMI >27 kg/m2 (with obesity related comorbidities)
- Patients willing and able to comply with study requirements for follow-up
- Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
Key exclusion criteria (10 listed)
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
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 |
|---|---|---|
| Endobariatric procedureEndoscopic sleeve gastroplasty or transoral outlet reduction | Procedure or surgery | Endoscopic sleeve gastroplasty/Transoral outlet reduction |
Primary outcome
Changes in body weight after various endoscopic bariatric therapies
Time frame: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure
The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.
1 secondary outcome
Changes in hormonal profiles after various endoscopic bariatric therapies
Time frame: Baseline/pre-procedure, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kenneth Park, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobariatric procedure in people with Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana Bancila, PhD (310-423-3872, Liliana.Bancila@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight after various endoscopic bariatric therapies (time frame: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure). 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 26 Aug 2024.