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ObesityEBTNCT04494048

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

An observational study of Obesity and Weight Loss, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Obesity, Weight Loss, Gastro Esophageal Reflux
What is being tested?
Endoscopic Bariatric Therapies
How many people
9,999 participants
Where
1 siteUnited States
Study dates
5 Apr 2016to 31 Oct 2035
Phase
Observational
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 to 89 years
  • All sexes
  • Adult, Older adult

Study population: Individuals who will undergo Endoscopic bariatric therapies.

Who may be able to join

  • Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
  • Above or equal to 18 years of age.

Who cannot join

  • Any patient who has not undergone or will undergo EBT for weight loss
  • Below 18 years of age.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Reem Z Sharaiha, MD, MSc. contact

646-962-2382

rzs9001@med.cornell.edu

Andrea M Herr, NP contact

646-962-2382

anb9057@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Reem Z Sharaiha, MD, 6469622382, rzs9001@med.cornell.edu

    Andrea M Herr, NP, 6469622382, anb9057@med.cornell.edu

    Recruiting

Other trials in United States

About this study

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.

Read the detailed description

Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs, endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or in conjunction with other weight loss treatment modules for patients who cannot or do not want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30 kg/m2) or BMI >27 with comorbidities.

This research is being done in order to find out if endoscopic bariatric therapies work as well as, or better or worse than, other currently available treatment modules to achieve weight loss.

The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.

Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.

Being tested
Endoscopic Bariatric Therapies
Medical subject headings
Obesity, Weight Loss, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Bariatric TherapiesOther

    Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy

Study groups in NCT04494048
Study groupRoleWhat they receive
Endoscopic Bariatric Therapies (EBT).patients undergoing Endoscopic Bariatric Therapies
Receives: Other: Endoscopic Bariatric Therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of weight of the various bariatric therapies

    Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.

    Measured: Baseline, 1 month, 6 months, and 1 year post procedure

  2. Safety of procedure measured by in the number of adverse events of procedure

    Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline

    Measured: at baseline

  3. Safety of procedure measured by in the number of adverse events that occur within 30 days

    Number of adverse events; Type (unexpected, expected, related, possibly related)

    Measured: Within 30 days of the procedure

Secondary outcomes (9)

  1. Technical success of each bariatric therapy.

    Technical success is the technical success of the procedure.

    Measured: through study completion at one year.

  2. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm

    Measured: 6 months, 1 year post procedure

  3. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg

    Measured: 6 months, 1 year post procedure

  4. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)

    Measured: 6 months, 1 year post procedure

  5. Change in the effect of Endoscopic Bariatric Therapies on reflux

    measuring change in gastrointestinal reflux disease (GERD) questionnaire answers

    Measured: Baseline, 6 months,and 1 year post procedure

  6. Change in the effect of Endoscopic Bariatric Therapies on reflux

    measuring change in ph measurement on ph manometry

    Measured: Baseline, 6 months,and 1 year post procedure

  7. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in fibroscan score

    Measured: Baseline, 6 months,and 1 year post procedure

  8. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in liver biopsy results

    Measured: Baseline, 6 months,and 1 year post procedure

  9. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )

    Measured: Baseline, 6 months,and 1 year post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start5 Apr 2016
  3. Primary completion31 Oct 2035 (estimated)
  4. Study completion31 Oct 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
9,999 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04494048
Sponsor's protocol ID
1510016654
Acronym
EBT
Status last verified
Apr 2026
First submitted
13 May 2020
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lahooti A, Westerveld D, Johnson K, Aneke-Nash C, Baig MU, Akagbosu C, Hanscom M, Buckholz A, Newberry C, Herr A, Schwartz R, Yeung M, Sampath K, Mahadev S, Kumar S, Carr-Locke D, Aronne L, Shukla A, Sharaiha RZ. Improvement in obesity-related comorbidities 5 years after endoscopic sleeve gastroplasty: a prospective cohort study. Gastrointest Endosc. 2025 Jul;102(1):26-36. doi: 10.1016/j.gie.2024.12.017. Epub 2024 Dec 16.

    PubMed 39694295

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Weight Loss, run by Weill Medical College of Cornell University 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 2 inclusion and 2 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 23 Apr 2026. 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?

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 Reem Z Sharaiha, MD, MSc. (646-962-2382, rzs9001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of weight of the various bariatric therapies (time frame: Baseline, 1 month, 6 months, and 1 year post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04494048, which also lists 1 linked publication.

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 23 Apr 2026.

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