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Non-Alcoholic Fatty Liver DiseaseNCT05611567

Endoscopic Gastric Plication Using the POSE2.0 Technique for Management of Fatty Liver Disease

A study testing POSE2.0 procedure and Life style and behavioral intervention in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Emirates Health Services (EHS) at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Alcoholic Fatty Liver Disease, Obesity
What is being tested?
POSE2.0 procedure and Life style and behavioral intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited Arab Emirates
Study dates
20 Jan 2020to 1 Sep 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form.
  • Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
  • Subjects age >=18 years old.
  • Hepatic steatosis from NAFLD, as defined by a controlled attenuation parameter ≥ 280 dB/m without alternate cause of liver disease measured by a Fibroscan XL.
  • Body Mass Index ≥ 30kg/m2
  • If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
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  • Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
  • Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  • Have not taken any prescription or over-the-counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
  • Subjects must be willing to possibly forego any future weight loss procedures (i.e. Vertical Sleeve Gastrectomy) given the unknown long-term effects.
  • Residing within a reasonable distance from the Investigator's treating office (~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits.

Who cannot join

  • History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  • Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
  • Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
  • Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
  • Pancreatic insufficiency/disease.
  • History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
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  • Pregnancy or plans of pregnancy in the next 12 months.
  • History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
  • Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
  • Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
  • History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
  • Active gastric erosion, lesion, or gastric/duodenal ulcer.
  • History of or current platelet or coagulation dysfunction, such as hemophilia.
  • History or present use of insulin or insulin derivatives for treatment of diabetes.
  • Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.
  • If smoker, plans to quit smoking in the year after enrollment.
  • Portal hypertension and/or varices.
  • Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  • Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
  • Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
  • Patient score >2 in any of the 9 identified symptoms on the Gastroparesis Cardinal Symptom Index (GCSI)
  • Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
  • Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  • Participating in another clinical study.
  • Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
  • Physician's assessment that the subject is not an appropriate candidate.
  • -

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • Obaidulla Hospital, Emirates Health Services, Ministry of Health, United Arab Emirates

    Ras al-Khaimah

Other trials in United Arab Emirates

About this study

Official title: A Feasibility Study Examing the Primary Obesity Surgery Endoluminal (POSE) 2.0 Procedure for the Management of Non-alcoholic Fatty Liver Disease

Primary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Adults with obesity and non-alcoholic NAFLD were allocated based on preference and motivation to undergo the POSE 2.0 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE2.0 procedures on NAFLD parameters and metabolic profile. Co-primary endpoints included improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary endpoints included total body weight loss (TBWL), change in serum measures of hepatic steatosis and insulin resistance, and device safety.

Being tested
POSE2.0 procedure, Life style and behavioral intervention
Medical subject headings
Non-alcoholic Fatty Liver Disease, Obesity

What participants receive

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

  • POSE2.0 procedureProcedure or surgery

    The POSE 2.0 involves full-thickness plications by suture anchor pairs that shorten and tabularize the stomach along its greater curvature. The POSE 2.0 procedure was carried out using the Incisionless Operating Platform (USGI Medical, San Clemente, CA)

  • Life style and behavioral interventionBehavioural

    The intervention focuses on caloric restriction diet, physical activity, and behavioral modification targeted toward weight loss and administered by a health care professional months for the 12 months duration of the study.

Study groups in NCT05611567
Study groupRoleWhat they receive
POSE2.0ExperimentalThis is the arm that got the POSE2.0 procedure. The POSE 2.0 involves full-thickness plications by suture anchor pairs that shorten and tabularize the stomach along its greater curvature. The POSE 2.0 procedure was carried out using the Incisionless Operating Platform (USGI Medical, San Clemente, CA). This device is registered and commercially available in the United Arab Emirates for the management of obesity.
Receives: Procedure: POSE2.0 procedure; Behavioral: Life style and behavioral intervention
Life style and behavioral interventionActive comparatorThis is the comparator arm that received lifestyle modification alone for weight loss and NAFLD management (representing the comparative control group). This group underwent the same lifestyle program and clinical follow-up as the POSE2.0, but under a parallel standard clinical care pathway, which is the standard clinical pathway in the hospital this study was conducted in.
Receives: Behavioral: Life style and behavioral intervention

What is being measured

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

  1. Change in controlled attenuation parameter (CAP)

    Measured by Fibroscan XL

    Measured: 12 months

  2. Change in liver stiffness

    Measured by Fibroscan XL

    Measured: 12 months

Secondary outcomes (1)

  1. Percent resolution of hepatic steatosis at 12 months

    Measured by fibroscan XL

    Measured: 12 months

Timeline

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

  1. First posted10 Nov 2022
  2. Study start20 Jan 2020
  3. Primary completion15 Mar 2022
  4. Study completion1 Sep 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05611567
Sponsor's protocol ID
DD/CTMD2/019/2019
Status last verified
Nov 2022
First submitted
27 Oct 2022
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Select IPD could be shared after approval of the UAE Ministry of Health and after signing a data-sharing agreement.

Publications

  • AlKhatry M, Rapaka B, Maselli DB, Abboud DM, Brunaldi VO, Mahmoud T, Ghazi R, Abdul Razzak F, Gala K, Joudah I, Housen F, Al Qadi S, Vargas EJ, Storm AC, Abu Dayyeh BK. Improvements in hepatic steatosis, obesity, and insulin resistance in adults with nonalcoholic fatty liver disease after the primary obesity surgery endoluminal 2.0 procedure. Endoscopy. 2023 Nov;55(11):1028-1034. doi: 10.1055/a-2117-6274. Epub 2023 Jun 26.

    PubMed 37364600

Questions about this trial

What is this clinical trial studying?

A study testing POSE2.0 procedure and Life style and behavioral intervention in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Emirates Health Services (EHS) at 1 site in United Arab Emirates.

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 11 inclusion and 27 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 Arab Emirates. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 controlled attenuation parameter (CAP) (time frame: 12 months). The study lists 2 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 NCT05611567, 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 10 Nov 2022.

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Clinical Trial NCT05611567 | AzTrials