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ObesityEMBTsNCT05725967

Endoscopic Metabolic and Bariatric Therapies

An observational study of Obesity and Obesity, Morbid, run by Christopher C. Thompson, MD, MSc at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Primary Obesity Endoscopic Procedures, Endoscopic Revision of Bariatric Surgical Procedures and Bariatric Surgery Procedures
How many people
5,000 participants
Where
1 siteUnited States
Study dates
8 Jul 2022to 28 May 2029
How long will I take part?
10 Years
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.

Who may be able to join

  • patients from Mass General Brigham
  • any patient having an endoscopic primary obesity procedure
  • any patient having an endoscopic post-bariatric surgical revision procedure
  • any patient having a bariatric surgical procedure

Who cannot join

  • patients without past surgical and medical history medical records in the Mass General Brigham system
  • patients unwilling to allow for medical record review at Mass General Brigham

Trial locations and contacts

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

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Read the detailed description

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Being tested
Primary Obesity Endoscopic Procedures, Endoscopic Revision of Bariatric Surgical Procedures, Bariatric Surgery Procedures, Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction, Intragastric Balloon
Keywords
Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy, pylorus sparing antral myotomy (PSAM), gastric emptying breath test (GEBT)
Medical subject headings
Obesity, Obesity, Morbid, Gastric Fistula, Stomach Ulcer, Abdominal Pain, Obesity, Abdominal, Postoperative Complications, Weight Gain

What participants receive

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

  • Primary Obesity Endoscopic ProceduresProcedure or surgery

    Also called ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs

    Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).

  • Endoscopic Revision of Bariatric Surgical ProceduresProcedure or surgery

    Also called TORe, ROSE, APC

    Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.

  • Bariatric Surgery ProceduresProcedure or surgery

    Also called RYGB, LSG, LAGB

    Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)

  • Endoscopic Sleeve Gastroplasty, Trans-oral Outlet ReductionDevice

    Also called ESG, TORe

    Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.

  • Intragastric BalloonDevice

    Also called IGB

    An endoscopic bariatric procedure involving the placement of an intragastric balloon.

  • Primary obesity surgery endoluminal, Restorative obesity surgery endoluminalDevice

    Also called POSE, ROSE

    Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.

  • Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral MyotomyDevice

    Also called APC, GEM, BEAM, PSAM

    Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.

  • Aspiration TherapyDevice

    Also called Aspire

    Placement of an aspiration therapy device for the treatment of obesity.

Study groups in NCT05725967
Study groupRoleWhat they receive
Primary Obesity Endoscopic ProceduresPrimary endoscopic procedures for treatment of obesity.
Receives: Procedure: Primary Obesity Endoscopic Procedures; Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction; Device: Intragastric Balloon; Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal; Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy; Device: Aspiration Therapy
Endoscopic Revision of Bariatric Surgical ProceduresEndoscopic revision of post-bariatric surgical complications.
Receives: Procedure: Endoscopic Revision of Bariatric Surgical Procedures; Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction; Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal; Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
Bariatric Surgery ProceduresBariatric surgical procedures.
Receives: Procedure: Bariatric Surgery Procedures

What is being measured

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

  1. Change in weight from pre-procedure to 10 years

    %TBWL

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  2. Change in hypertension from pre-procedure to 10 years using blood pressure measurements

    Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  3. Change in hypertension from pre-procedure to 10 years using medication dosages

    Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  4. Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years

    Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  5. Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years

    Change of HgA1c (%) by comparing lab values from baseline through 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  6. Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years

    Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  7. Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years

    Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  8. Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years

    Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  9. Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years

    Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  10. Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years

    Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  11. Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years

    Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  12. Change in rate of adverse events from procedure to 10 years

    Change in rate of adverse events post-procedure through 10 years

    Measured: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  13. Change in comorbidity medication dosages from baseline to 10 years

    Change of dosage of comorbidity medications compared to baseline

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

Secondary outcomes (5)

  1. Change in gastric motility from baseline to 10 years

    Gastric emptying breath test

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  2. Change in PYY gut hormones from baseline to 10 years

    PYY lab values will be compared to baseline

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  3. Change in GLP1 gut hormones from baseline to 10 years

    GLP1 lab values will be compared to baseline

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  4. Change in ghrelin hormones from baseline to 10 years

    Ghrelin lab values will be compared to baseline

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  5. Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years

    Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures

    Measured: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery

Timeline

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

  1. First posted13 Feb 2023
  2. Study start8 Jul 2022
  3. Primary completion28 May 2028 (estimated)
  4. Study completion28 May 2029 (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
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05725967
Sponsor's protocol ID
2022P001757
Acronym
EMBTs
Status last verified
Nov 2025
First submitted
29 Dec 2022
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Depending on the range of data and publication status, the PI will consider de-identified data sharing with a data transfer agreement in place after discussion of parameters and study design.

Publications

  • Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.

    PubMed 35908555

  • Jirapinyo P, Thompson CC. Endoscopic gastric plication for the treatment of weight regain after Roux-en-Y gastric bypass (with video). Gastrointest Endosc. 2022 Jul;96(1):51-56. doi: 10.1016/j.gie.2022.02.051. Epub 2022 Mar 5.

    PubMed 35259393

  • de Moura DTH, Hirsch BS, Boghossian MB, de Medeiros FS, McCarty TR, Thompson CC, de Moura EGH. Low-cost modified endoscopic vacuum therapy using a triple-lumen tube allows nutrition and drainage for treatment of an early post-bariatric surgery leak. Endoscopy. 2022 Jul;54(7):E376-E377. doi: 10.1055/a-1540-5870. Epub 2021 Aug 9. No abstract available.

    PubMed 34374043

  • de Moura DTH, de Freitas Junior JR, de Souza GMV, de Oliveira GHP, McCarty TR, Thompson CC, de Moura EGH. Endoscopic management of acute leak after sleeve gastrectomy: principles and techniques. Endoscopy. 2022 Jul;54(7):E327-E328. doi: 10.1055/a-1525-1661. Epub 2021 Jul 9. No abstract available.

    PubMed 34243196

  • Sanchez-Luna SA, Thompson CC, De Moura EGH, de Medeiros FS, De Moura DTH. Modified endoscopic vacuum therapy: Are we ready for prime time? Gastrointest Endosc. 2022 Jun;95(6):1281-1282. doi: 10.1016/j.gie.2021.12.049. No abstract available.

    PubMed 35589208

  • Bazarbashi AN, Dolan RD, McCarty TR, Jirapinyo P, Thompson CC. Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis. Surg Endosc. 2022 Jun;36(6):4099-4107. doi: 10.1007/s00464-021-08731-4. Epub 2021 Oct 20.

    PubMed 34669046

  • Jirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29.

    PubMed 35348970

  • Argueta PP, Salazar M, Vargo JJ, Chahal P, Rodriguez JJ, Simons-Linares CR, Thompson CC. Thirty-Day Readmission After Bariatric Surgery: Causes, Effects on Outcomes, and Predictors. Dig Dis Sci. 2022 Mar;67(3):834-843. doi: 10.1007/s10620-021-06934-2. Epub 2021 Jun 24.

    PubMed 34169433

  • Jirapinyo P, McCarty TR, Dolan RD, Shah R, Thompson CC. Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):511-524.e1. doi: 10.1016/j.cgh.2021.03.017. Epub 2021 Mar 13.

    PubMed 33727164

  • Singh S, Bazarbashi AN, Khan A, Chowdhry M, Bilal M, de Moura DTH, Jirapinyo P, Thakkar S, Thompson CC. Primary obesity surgery endoluminal (POSE) for the treatment of obesity: a systematic review and meta-analysis. Surg Endosc. 2022 Jan;36(1):252-266. doi: 10.1007/s00464-020-08267-z. Epub 2021 Feb 1.

    PubMed 33523277

  • Thompson CC, Jirapinyo P, Shah R, Simsek C. Gastroplasty With Endoscopic Myotomy (GEM) for the Treatment of Obesity: Preliminary Efficacy and Physiologic Results. Gastroenterology. 2022 Nov;163(5):1173-1175. doi: 10.1053/j.gastro.2022.07.077. Epub 2022 Aug 10. No abstract available.

    PubMed 35961376

  • Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc. 2022 Sep;96(3):479-486. doi: 10.1016/j.gie.2022.04.1346. Epub 2022 May 11.

    PubMed 35568242

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Obesity, Morbid, run by Christopher C. Thompson, MD, MSc 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 4 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: enrolling by invitation, as of the sponsor's last update on 2 Dec 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight from pre-procedure to 10 years (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.). The study lists 13 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 NCT05725967, which also lists 12 linked publications.

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 2 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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