Obesity Trial, Recruiting NCT06616714 Sponsor: Laterza Lucrezia Condition: Obesity
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Obesity Trial, Recruiting

NCT06616714
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 70 years
  • People with a Body Mass Index (BMI) between 30 and 40 (a measure of weight relative to height that falls in the obese range)
  • People willing and able to understand and follow the study protocol
  • People who have been diagnosed with Crohn's disease or Ulcerative Colitis at least 3 months before the screening visit
  • People whose IBD (inflammatory bowel disease) has been in remission (inactive, well-controlled disease) for at least 6 months before screening, without the use of steroid medications during that time — as confirmed by specific disease activity scores used by the medical team
  • People who have been on a stable, unchanged treatment dose for their IBD for at least 8 weeks before the start of the study

Who may not be able to join:

  • People with an active Helicobacter pylori infection causing damage (erosions or ulcers) to the stomach or the first part of the small intestine
  • People with a structural or movement disorder affecting the stomach or oesophagus (food pipe)
  • People who have previously had weight-loss (bariatric) surgery, or any other surgery that has changed the shape of the oesophagus, stomach, or upper small intestine
  • People with an ongoing or active cancer diagnosis within the last 5 years
  • People who have had a heart attack in the past 6 months, or who have severe heart failure (classified as Class III or IV by medical criteria)
  • People with drug or alcohol dependency
  • People with patterns of bulimia or binge eating
  • People with thyroid disease that is not well controlled
  • People who are pregnant or breastfeeding
  • People with psychiatric conditions, cooperation difficulties, or a history of low compliance that the medical team considers a barrier to participation
  • People with liver cirrhosis at any stage, or with a specific liver function score above 15 (confirm with trial site)
  • People with severely reduced kidney function, based on a specific kidney filtration measurement below a set threshold
  • People currently participating in another clinical study, or who have participated in a study involving an experimental drug within the past 30 days (or within 5 times the drug's clearance period, whichever is longer)
  • People whose IBD is currently active, as determined by specific disease activity scores or by current use of systemic steroids to manage disease symptoms
  • People with any other health condition that the trial investigator judges could put them at risk from the treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Lucrezia Laterza, PI, Fondazione Policlinico A. Gemelli IRCCS, Rome

Phone: +390630156876

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Laterza Lucrezia
Registry
ClinicalTrials.gov
Start date
20 May 2024
Est. completion
20 May 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Feasibility Assessment Based on Completion Rate of ESG Procedure Without Complications

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov