ClinicalTrials.gg
Enrolling by invitationNCT07493967Updated Jun 10, 2026

Short and Long Term Clinical and Patient-Reported Outcomes Associated With Intragastric Balloon Placement in Patients With Nonalcoholic Fatty Liver Disease

An observational study in NAFLD, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States — 60 open to participants now, 93 under way, 13 of them phase 3. Non-alcoholic Fatty Liver Disease · United States.

Planned enrollment
28th of 85
200 · median 90
Started
2024
with 28 others
Observational
85 of 547
13 open now
Primary completion
2026-12
later than 30 of 92 live
Registered
512th of 547
by date

Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, this one is the 28th largest by planned enrollment of the 85 observational ones that give a count, is one of 29 that started in 2024, is one of 85 observational ones, reaches primary completion later than 30 of the 92 other live ones, and was the 512th registered.

Non-alcoholic Fatty Liver Disease

1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.

Browse Non-alcoholic Fatty Liver Disease studies →

Open to participants now

60 of the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States are open now. Recruiting first, the newest first:

55 more — sign in →

All 60 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, or all of them as a file.
02

Study summary

This study aims to enroll a robust cohort of NAFLD patients who undergo Intragastric Balloon placement through a multidisciplinary program approach to evaluate clinical and patient-reported outcomes for at least one-year post-placement.

03

Conditions studied

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This single-center, prospective cohort study will investigate NAFLD patients enrolled in a multidisciplinary immunoglobulin B placement program seen at Methodist Dallas Medical Center (MDMC) beginning January 2023 through December 2026.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Obese (defined as a >30 kg/m2 )
  • Men and women scheduled to undergo immunoglobulin B placement at Methodist Dallas Medical Center(MDMC)
  • 18 years or older in age
  • Able to read and understand the study information
  • Personally signed and dated form indicating that the subject has been informed of all pertinent aspects of the study
  • Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures

Exclusion criteria

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Pregnant women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes in Weight

    MeasureTotal body weight loss

    Time frame: through study completion, up to 18 months

  2. Body Mass Index

    Measure Body Mass Index

    Time frame: 1 year

  3. Waist to hip ratio

    Measure Waist-to-hip ratio

    Time frame: 1 year

  4. Aminotransaminases

    Measure Aminotransaminases

    Time frame: 1 year

  5. Fasting Lipids

    Measure Fasting Lipids

    Time frame: 1 year

  6. Fasting Glucose

    Measure Fasting Glucose

    Time frame: 1 year

  7. HbA1c

    Measure HbA1c

    Time frame: 1 year

  8. Changes in liver histology parameters

    Nonalcoholic Fatty Liver Disease activity score- Min: 1.455 ,Max: 0.675

    Time frame: 1year

  9. Changes in liver histology parameters

    Magnetic resonance electrography- detected liver stiffness/ Fibrosis score-Min:2.5 kilopascals, Max: 3.0 kilopascals

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Publications

  • Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava JL, Wing RR. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology. 2010 Jan;51(1):121-9. doi: 10.1002/hep.23276. PubMed 19827166 ↗
  • English WJ, DeMaria EJ, Hutter MM, Kothari SN, Mattar SG, Brethauer SA, Morton JM. American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2020 Apr;16(4):457-463. doi: 10.1016/j.soard.2019.12.022. Epub 2020 Jan 3. PubMed 32029370 ↗
  • Bazerbachi F, Vargas EJ, Rizk M, Maselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK. Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Jan;19(1):146-154.e4. doi: 10.1016/j.cgh.2020.04.068. Epub 2020 Apr 30. PubMed 32360804 ↗
  • Frutos MD, Morales MD, Lujan J, Hernandez Q, Valero G, Parrilla P. Intragastric balloon reduces liver volume in super-obese patients, facilitating subsequent laparoscopic gastric bypass. Obes Surg. 2007 Feb;17(2):150-4. doi: 10.1007/s11695-007-9040-3. PubMed 17476864 ↗
  • Popov VB, Thompson CC, Kumar N, Ciarleglio MM, Deng Y, Laine L. Effect of Intragastric Balloons on Liver Enzymes: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2016 Sep;61(9):2477-87. doi: 10.1007/s10620-016-4178-2. Epub 2016 May 20. PubMed 27207181 ↗
  • Sena E, Manzano-Nunez R, Rivera-Esteban J, Pericas JM. Patient-reported outcomes in NAFLD/NASH clinical trials: A blind spot that needs addressing. JHEP Rep. 2022 Sep 22;5(1):100597. doi: 10.1016/j.jhepr.2022.100597. eCollection 2023 Jan. No abstract available. PubMed 36536958 ↗
  • Twiss J, Whalley D, Doward L, Balp MM, Brass CA, Cryer D, Sanyal A, Anstee QM. Validation of NASH-CHECK: a novel patient-reported outcome measure for nonalcoholic steatohepatitis. J Patient Rep Outcomes. 2023 Jul 14;7(1):69. doi: 10.1186/s41687-023-00589-5. PubMed 37450086 ↗
  • Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003. PubMed 14739871 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.

Of 159 non-industry observational studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 125. This study's planned 34 months is below that.

Counting every sponsor, half of 170 studies reached it within 49 months; a quarter within 25 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2024
First posted
Mar 27, 2026
StartActual
Feb 23, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Feb 2027
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07493967
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Feb 23, 2024
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Parvez Mantry
principal investigator · Methodist Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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