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Recruiting

NCT Number: NCT06894498

Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The BMI Clinic, Double Bay, New South Wales, Australia

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About this study

Includes retrospective data collection and one prospective visit

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is ≥ 18 years of age at the time of the ESG procedure
  • Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
  • Subject completed follow-up 1-year from the ESG procedure for weight loss management
  • Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
  • Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
  • Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
  • Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion criteria

  • None

Treatment and study plan

No Intervention: Observational Cohort

Other

No Intervention, Observational Cohort

Primary outcomes

  1. Proportion of subjects that maintain clinically significant weightloss at five-year visit

    Time frame: TBWL assessed at five-years post ESG

    Mean % Total Body Weight Loss (TBWL) at 5-year visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime Oriol

CONTACT

[email protected]

978-790-8009

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: LIGHT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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