Weight LossNCT04006002
Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures
An observational study of Weight Loss and Reflux, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Reflux
- What is being tested?
- Metabolic and Hormonal profile
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 28 Jan 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only participants who meet all eligibility criteria will be enrolled in the study. Participants who meet all eligibility criteria and have successfully completed the screening requirements will be asked to sign a Study Consent. Patients undergoing endoscopic or laparoscopic weight loss procedures will be included.
Who may be able to join
- BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
- Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
- Both male and female subjects will be included in the study.
- Subjects from any ethnic background will be included in the study.
- Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
- Successfully complete the screening process.
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- Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
- Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
- Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.
Who cannot join
- Pregnant or planning to become pregnant during period of study participation.
- Female participants who are breast-feeding.
- Severe Immunodeficiency.
- Severe malnutrition.
- The participant has life expectancy of less than 1 year due to other medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy
The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.
Read the detailed description
We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.
- Conditions
- Weight Loss, Reflux
- Being tested
- Metabolic and Hormonal profile
- Medical subject headings
- Weight Loss, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic and Hormonal profileOther
To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Sleeve Gastrectomy | This group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss Receives: Other: Metabolic and Hormonal profile | |
| Laproscopic Sleeve Gastrectomy | This group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss Receives: Other: Metabolic and Hormonal profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with GERD before and after intervention
Percentage of participants with GERD (>6% abnormal esophageal acid exposure calculated via BRAVO pH monitoring for 96 hrs ) before and at 12 months after an endoscopic or surgical bariatric intervention
Measured: 1 years
Secondary outcomes (1)
Compare gastric emptying after intervention
To compare gastric emptying and small bowel transit times, before and at 12 months after an endoscopic or surgical bariatric intervention using wireless capsule technology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion28 Jan 2022
Why it stopped: Not able to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petros Benias, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006002
- Sponsor's protocol ID
- 19-0112
- Status last verified
- Jan 2022
- First submitted
- 7 Jun 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28.
PubMed 27989851Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
PubMed 29110192Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.
PubMed 18355825
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04006002
- Acronym / sponsor ID
- 19-0112
- Conditions
- Weight Loss, Reflux
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not able to recruit enough patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 2 Jul 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.
The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.
Detailed description
We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Sleeve Gastrectomy | – | Other: Metabolic and Hormonal profileThis group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss |
| Laproscopic Sleeve Gastrectomy | – | Other: Metabolic and Hormonal profileThis group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only participants who meet all eligibility criteria will be enrolled in the study. Participants who meet all eligibility criteria and have successfully completed the screening requirements will be asked to sign a Study Consent. Patients undergoing endoscopic or laparoscopic weight loss procedures will be included.
Key inclusion criteria (9 listed)
- BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
- Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
- Both male and female subjects will be included in the study.
- Subjects from any ethnic background will be included in the study.
- Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
Key exclusion criteria (5 listed)
- Pregnant or planning to become pregnant during period of study participation.
- Female participants who are breast-feeding.
- Severe Immunodeficiency.
- Severe malnutrition.
- The participant has life expectancy of less than 1 year due to other medical conditions.
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 |
|---|---|---|
| Metabolic and Hormonal profileTo assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention | Other | Endoscopic Sleeve Gastrectomy, Laproscopic Sleeve Gastrectomy |
Primary outcome
Percentage of participants with GERD before and after intervention
Time frame: 1 years
Percentage of participants with GERD (>6% abnormal esophageal acid exposure calculated via BRAVO pH monitoring for 96 hrs ) before and at 12 months after an endoscopic or surgical bariatric intervention
1 secondary outcome
Compare gastric emptying after intervention
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Not able to recruit enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 27989851Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28.
- Background: PubMed 29110192Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
- Background: PubMed 18355825Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.
- Individual participant dataSharing planned: No
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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.
Petros Benias, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Reflux, run by Northwell Health at 1 site in United States.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Feb 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 States. 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 was stopped early (reason given: Not able to recruit enough patients). Results are not available in the source record.
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?
Percentage of participants with GERD before and after intervention (time frame: 1 years). 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 NCT04006002, which also lists 3 linked publications.
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 14 Feb 2022.