ObesityNCT02578836
Transoral Gastric Volume Reduction as an Intervention for Weight Management
A study testing Fogel Gastroplasty in people with Obesity and Overweight, run by University of Miami at 1 site in United States.
Trial summary
This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). The purpose of the study is to: Document that weight loss occurs (12 months) Determine if it alters general wellbeing (emotionally and physically) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Fogel Gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to Nov 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
- Subject has a BMI between 28 and 34.9
- Subject is willing to complete all follow-up visits after procedure ( 3, 6 and 12 months)
Who cannot join
- Patients that are not willing to participate in the study
- Patients with history of Gastrointestinal tumors, Gastric Cancer, previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy, esophageal or gastric varices, or gastroparesis,
- Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility or Hiatal Hernia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Clinical Research Building
Miami, Florida, 33136
About this study
This study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). The purpose of the study is to:
- Document that weight loss occurs (12 months)
- Determine if it alters general wellbeing (emotionally and physically)
Read the detailed description
This will be a prospective study evaluating the percentage of weight loss in patients that have undergo the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). Fogel's Gastroplasty is a procedure where The subject will be placed under general anesthesia in accordance with the Institution's standard practice. The procedure will last approximately 1-2 hours. Following induction of anesthesia, the overtube will be placed, a gastroscope will be inserted to examine esophageal and gastric anatomy and re-confirm there are no anatomical contraindications to the procedure. The gastroscope will also be used to record images of the stomach prior to insertion of the OverStitch. Once the examination is complete the gastroscope will be removed. The OverStitch system will then be inserted orally to the per-operative site. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch. Once complete, the OverStitch system will be removed and a standard gastroscope will be inserted to record post procedure endoscopic images.
Anthropometric measurements as Weight, Height, BMI and Waist Circumference will be collected at Baseline, 3, 6 and 12 months after procedure
- Conditions
- Obesity, Overweight, Weight Loss
- Being tested
- Fogel Gastroplasty
- Keywords
- Weight Loss, Overweight, Endoscopic treatment for obesity
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fogel GastroplastyProcedure or surgery
Also called Endoscopic Vertical Gastroplasty
The subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition
| Study group | Role | What they receive |
|---|---|---|
| Fogel Gastroplasty | Experimental | The subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition Receives: Procedure: Fogel Gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 12 months
Secondary outcomes (4)
Emotional Wellbeing
Measured by self administration of quality of life questionnaire SF-36
Measured: 12 months
Change in blood pressure
Measured: baseline to 12 months
Change in cholesterol level
Measured: baseline to 12 months
Change in glucose levels
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start1 Aug 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Study was withdrawn due to PI decision
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 University of MiamiThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Fogel, University of Miami
- Investigators
- Roberto Fogel, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578836
- Sponsor's protocol ID
- 20150200
- Status last verified
- May 2017
- First submitted
- 15 Oct 2015
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Gastric Volume Reduction as an Intervention for Weight Management
- ClinicalTrials.gov ID
- NCT02578836
- Acronym / sponsor ID
- 20150200
- Conditions
- Obesity, Overweight, Weight Loss
- Keywords
- Weight Loss, Overweight, Endoscopic treatment for obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to PI decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- 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 study assesses weight loss from the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). The purpose of the study is to:
- Document that weight loss occurs (12 months)
- Determine if it alters general wellbeing (emotionally and physically)
Detailed description
This will be a prospective study evaluating the percentage of weight loss in patients that have undergo the Endoscopic Vertical Gastroplasty or Fogel Gastroplasty (FG). Fogel's Gastroplasty is a procedure where The subject will be placed under general anesthesia in accordance with the Institution's standard practice. The procedure will last approximately 1-2 hours. Following induction of anesthesia, the overtube will be placed, a gastroscope will be inserted to examine esophageal and gastric anatomy and re-confirm there are no anatomical contraindications to the procedure. The gastroscope will also be used to record images of the stomach prior to insertion of the OverStitch. Once the examination is complete the gastroscope will be removed. The OverStitch system will then be inserted orally to the per-operative site. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch. Once complete, the OverStitch system will be removed and a standard gastroscope will be inserted to record post procedure endoscopic images.
Anthropometric measurements as Weight, Height, BMI and Waist Circumference will be collected at Baseline, 3, 6 and 12 months after procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fogel Gastroplasty | Experimental | Procedure: Fogel GastroplastyThe subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
- Subject has a BMI between 28 and 34.9
- Subject is willing to complete all follow-up visits after procedure ( 3, 6 and 12 months)
Key exclusion criteria (3 listed)
- Patients that are not willing to participate in the study
- Patients with history of Gastrointestinal tumors, Gastric Cancer, previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy, esophageal or gastric varices, or gastroparesis,
- Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility or Hiatal Hernia
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 |
|---|---|---|
| Fogel GastroplastyAlso: Endoscopic Vertical GastroplastyThe subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition | Procedure or surgery | Fogel Gastroplasty |
Primary outcome
Weight Loss
Time frame: 12 months
4 secondary outcomes
Emotional Wellbeing
Time frame: 12 months
Change in blood pressure
Time frame: baseline to 12 months
Change in cholesterol level
Time frame: baseline to 12 months
Change in glucose levels
Time frame: baseline to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- 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.
Roberto Fogel, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fogel Gastroplasty in people with Obesity and Overweight, run by University of Miami 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 Aug 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
Weight Loss (time frame: 12 months). 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 31 Aug 2017.