ObesityESGORTNCT04200144
Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
A study testing Endoscopic sleeve gastroplasty in people with Obesity and Endoscopic Sleeve Gastroplasty, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial. Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility
- What is being tested?
- Endoscopic sleeve gastroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2020to 2 Dec 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants have to fulfill the following criteria for participating in the study:
- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol
Who cannot join
- Active gastric ulcer during the last 6 months
- Organic or motility disorder of the stomach and / or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- Ongoing or active malignancy during the last 5 years
- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification
Show all 15Show fewer
- Drug or alcohol abuse
- Bulimic or binge eating pattern
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease
- Pregnancy, breastfeeding
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- Hiatal hernia > 5 cm
- Currently participating in other study
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Ivo Boskoski, MD, PhD, 00390630156580, ivo.boskoski@policlinicogemelli.it
About this study
Official title: An Open-label, Randomized, Controlled Clinical Trial on the Effects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota
This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial.
Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body weight. All patients will be followed until the planned end of the study after 36 months from the ESG procedure.
Read more
To study the effects of endoscopic gastroplasty on weight, metabolic risk factors, quality of life, satiety, gastrointestinal motility and gut microbiota compared to standard medical treatment control group.
Primary endpoint:
- Total body weight loss (%)
Secondary endpoints:
- Metabolic risk factors (e.g. lipid profile) and anthropometric measurements (e.g hip and waist circumference)
- Body composition
- Quality of life
- Gastroesophageal reflux disease
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non- Alcoholic-Steato-Hepatitis (NASH)
- Satiety
- Gut microbiota
Exploratory endpoints:
- Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
- Gastrointestinal motility
- Conditions
- Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility, Gastric Hormones, Microbiota, Quality of Life
- Being tested
- Endoscopic sleeve gastroplasty
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplastyDevice
Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)
| Study group | Role | What they receive |
|---|---|---|
| active endoscopic treatment | Active comparator | Patients that will undergo Endoscopic Sleeve Gastroplasty Receives: Device: Endoscopic sleeve gastroplasty |
| standard medical therapy control diet group | Active comparator | Patients that will undergo diet Receives: Device: Endoscopic sleeve gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight loss
Total body weight loss (%) measurement in kg and BMI
Measured: 12 months
Total body weight loss
Total body weight loss (%) measurement in kg and BMI
Measured: 36 months
Secondary outcomes (6)
Non-Alcoholic Fatty Liver Disease evaluation
Non-Alcoholic Fatty Liver Disease
Measured: 12 months
Non- Alcoholic-Steato-Hepatitis evaluation
Non- Alcoholic-Steato-Hepatitis
Measured: 12 months
Gut microbiota characterization
Gut microbiota
Measured: 6 months
Evaluation for Gastroesophageal reflux disease
Gastroesophageal reflux disease
Measured: 12, 24, 36 months
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
Measured: Baseline and 6 months
performing of gastric emptying scintigraphy for gastrointestinal motility
Gastrointestinal motility evaluation
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start4 Feb 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOSKOSKI IVO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200144
- Sponsor's protocol ID
- 2837
- Acronym
- ESGORT
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled Clinical Trial on the Effects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota
- ClinicalTrials.gov ID
- NCT04200144
- Acronym / sponsor ID
- ESGORT / 2837
- Conditions
- Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility, Gastric Hormones, Microbiota, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial.
Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body weight. All patients will be followed until the planned end of the study after 36 months from the ESG procedure.
To study the effects of endoscopic gastroplasty on weight, metabolic risk factors, quality of life, satiety, gastrointestinal motility and gut microbiota compared to standard medical treatment control group.
Primary endpoint:
- Total body weight loss (%)
Secondary endpoints:
- Metabolic risk factors (e.g. lipid profile) and anthropometric measurements (e.g hip and waist circumference)
- Body composition
- Quality of life
- Gastroesophageal reflux disease
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non- Alcoholic-Steato-Hepatitis (NASH)
- Satiety
- Gut microbiota
Exploratory endpoints:
- Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
- Gastrointestinal motility
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active endoscopic treatment | Active comparator | Device: Endoscopic sleeve gastroplastyPatients that will undergo Endoscopic Sleeve Gastroplasty |
| standard medical therapy control diet group | Active comparator | Device: Endoscopic sleeve gastroplastyPatients that will undergo diet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol
Key exclusion criteria (15 listed)
- Active gastric ulcer during the last 6 months
- Organic or motility disorder of the stomach and / or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- Ongoing or active malignancy during the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic sleeve gastroplastyEndoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery) | Device | active endoscopic treatment, standard medical therapy control diet group |
Primary outcome
Total body weight loss
Time frame: 12 months
Total body weight loss (%) measurement in kg and BMI
Total body weight loss
Time frame: 36 months
Total body weight loss (%) measurement in kg and BMI
6 secondary outcomes
Non-Alcoholic Fatty Liver Disease evaluation
Time frame: 12 months
Non- Alcoholic-Steato-Hepatitis evaluation
Time frame: 12 months
Gut microbiota characterization
Time frame: 6 months
Evaluation for Gastroesophageal reflux disease
Time frame: 12, 24, 36 months
Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages
Time frame: Baseline and 6 months
performing of gastric emptying scintigraphy for gastrointestinal motility
Time frame: Baseline and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sleeve gastroplasty in people with Obesity and Endoscopic Sleeve Gastroplasty, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 15 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivo Boskoski, MD, PhD (+390630156580, ivo.boskoski@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body weight loss (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?
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 28 Feb 2024.