ObesityNCT02191501
Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity
A study testing Pyloric restriction in people with Obesity and Over Weight, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of the gastric pylorus to delay gastric emptying and treat obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Over Weight
- What is being tested?
- Pyloric restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2013to 9 Nov 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 65
- Male or female participants with a BMI >30 and < 45
- Female participants of childbearing age should not be pregnant, must have a negative serum or urine test and agree to use birth control for duration of the study.
- Participant did not undergo previous Roux-en-Y bypass with the gastric pouch limited to the cardia
Who cannot join
- Allergic to eggs or egg products, wheat, Gluten or Prolamins.
- currently on life saving oral medications
- Participants allergic to Scopolamine
- Participants allergic to botulinum toxin
- Participants who are currently on oral medications for their serious medical conditions.
- Recent tobacco cessation (within 3 months prior to planned enrollment) or plan to quit smoking during the study
Show all 21Show fewer
- Infection anywhere in the body at time of procedure or other diseases that would make participant unsuitable for treatment (e.g., systemic disease, HIV, malignancy, autoimmune disease, etc.)
- patients who cannot undergo endoscopy
- Active disease of the gastrointestinal tract including esophageal inflammation, varices or ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis
- Esophageal or cricopharyngeal narrowing or stricture; distorted esophagus or known esophageal pouch
- Heavily scarred, malignant, or poor quality (e.g., friable or overly compliant) tissue in area to be sutured
- Severe eating disorders such as bulimia (use of purgatives/laxatives) or anorexia nervosa
- Significant movement limitations of lower extremities (e.g., cannot walk without the use of, or assistance from, a brace, cane, crutch, another person, prosthetic device, wheelchair, or other assistive device or is severely limited in their ability to walk due to an arthritic, neurological, or orthopedic condition)
- Recently (within previous 3 months) prescribed or initiated therapy with medication(s) known to cause significant weight gain or likely to require treatment with such medication(s) during the study OR is currently taking or has taken within the previous 3 months prescription or over-the-counter weight loss medications (e.g., medications and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.). Additionally, use of such medications and weight loss/appetite suppressing dietary supplements are prohibited during the course of the trial including the screening period
- Participant has history of significant cardiovascular or pulmonary disease (e.g., myocardial infarct, unstable angina, congestive heart failure, pulmonary edema or COPD) or other significant cerebrovascular disease (e.g., stroke)
- Not a candidate for general or conscious/moderate sedation
- Participant is on anticoagulant therapy (heparin, coumadin, Plavix, Ticlid, etc.) and must discontinue use of 325 mg aspirin within 6 weeks of procedure
- Active substance abuse (e.g., alcohol or drugs). This is done with personal interview only. No drug tests are being performed to determine the active abuse
- The participant has life expectancy of less than 1 year due to other medical conditions
- The participant is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trials study endpoints
- Patients having Diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of the gastric pylorus to delay gastric emptying and treat obesity.
Read the detailed description
The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis and rationale for the study is that gastric pyloric restriction will cause early and prolonged satiety which will lead to decreased food intake and eventual weight loss. Both safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model.
Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes general history and physical examination, biochemical and laboratory analysis and informed consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline visit involves a four hour gastric emptying scan in order to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach. The baseline visit also includes nutritional counselling.
The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be prepped following usual practices and placed in a left lateral decubitus position. Following induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic evaluation of the esophagus, stomach and jejunum following standard medical practices will be performed. The endoscope with mounted suturing device is advanced through an over-tube to the antrum and assess target area for stitch placement (physician will select appropriate target site in relation to participant's anatomy). The number of sutures required will vary for each procedure based on the size of the pylorus; however, it is thought that one or two sutures across the pylorus will be sufficient enough to achieve a functional restriction of the pylorus.
Participants will to be observed for a minimum of 1 hour following the procedure to monitor for adverse events. Patients will be recommended to take the following medications in order to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting.
All participants will be required to adhere to the follow-up schedule outlined below unless they have withdrawn their consent or died. The reason(s) the participant is not followed will be documented by the investigator. Follow-up for all participants will include a telephone contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months after the procedure participants will undergo repeat endoscopy to access the stomach and the suture site.
- Conditions
- Obesity, Over Weight
- Being tested
- Pyloric restriction
- Keywords
- Obesity Treatment, Endoscopy, Pyloric Suturing, Pyloric restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyloric restrictionProcedure or surgery
The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract.
However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested.
| Study group | Role | What they receive |
|---|---|---|
| Pyloric restriction | Experimental | Endoscopic method of pyloric restriction in order to decrease gastric emptying. The hypothesis is that this will cause and early and prolonged satiety which will inturn lead to decreased food consumption and lead to weight loss. Receives: Procedure: Pyloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight loss
The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: [(Baseline Weight - Final 6 month Weight)/Baseline Weight] x 100%.
Measured: At 1, 3 and 6 months
Secondary outcomes (5)
Participant satisfaction
Participant satisfaction with clinical outcomes at 6 months post-procedure will be captured on an ordinal scale of 1 to 5 with 1 representing very satisfied and 5 representing not satisfied at all. The response will be tabulated and presented using descriptive statistics.
Measured: At 6 months post procedure
Delay in gastric emptying
A gastric emptying scan will be done prior to the endoscopic suturing procedure and four weeks after the endoscopic procedure to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach.
Measured: From baseline to 4 weeks post procedure
Change in BMI
BMI at 1, 3 and 6 months will be tabulated and summarized using descriptive statistics.
Measured: At 1, 3 and 6 Months
Percentage of Responders
Percentage of participants losing at least 5%, 10%, 15% and 20% of weight at 1, 3 and 6 months will be tabulated and reported.
Measured: At 1, 3 and 6 Months
Change in Medication Use.
If the participant is taking any medications for Obesity related complications such as Hypertension and Diabetes, then the dosage of those medications at 1, 3 and 6 months will be recorded and trends will be noted as either remained the same, decreased or increased.
Measured: At 1, 3 and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start7 May 2013
- Primary completion1 Aug 2017
- Study completion9 Nov 2017
Why it stopped: Suspended as we are looking for more durable method/device
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Larry Miller, Northwell Health
- Investigators
- Larry S Miller, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191501
- Sponsor's protocol ID
- Feinstein IRB#13-037B
- Status last verified
- Feb 2019
- First submitted
- 11 Jul 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity
- ClinicalTrials.gov ID
- NCT02191501
- Acronym / sponsor ID
- Feinstein IRB#13-037B
- Conditions
- Obesity, Over Weight
- Keywords
- Obesity Treatment, Endoscopy, Pyloric Suturing, Pyloric restriction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended as we are looking for more durable method/device
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- 7 May 2013 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 16 Jul 2014 (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.
The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of the gastric pylorus to delay gastric emptying and treat obesity.
Detailed description
The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis and rationale for the study is that gastric pyloric restriction will cause early and prolonged satiety which will lead to decreased food intake and eventual weight loss. Both safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model.
Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes general history and physical examination, biochemical and laboratory analysis and informed consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline visit involves a four hour gastric emptying scan in order to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach. The baseline visit also includes nutritional counselling.
The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be prepped following usual practices and placed in a left lateral decubitus position. Following induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic evaluation of the esophagus, stomach and jejunum following standard medical practices will be performed. The endoscope with mounted suturing device is advanced through an over-tube to the antrum and assess target area for stitch placement (physician will select appropriate target site in relation to participant's anatomy). The number of sutures required will vary for each procedure based on the size of the pylorus; however, it is thought that one or two sutures across the pylorus will be sufficient enough to achieve a functional restriction of the pylorus.
Participants will to be observed for a minimum of 1 hour following the procedure to monitor for adverse events. Patients will be recommended to take the following medications in order to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting.
All participants will be required to adhere to the follow-up schedule outlined below unless they have withdrawn their consent or died. The reason(s) the participant is not followed will be documented by the investigator. Follow-up for all participants will include a telephone contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months after the procedure participants will undergo repeat endoscopy to access the stomach and the suture site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyloric restriction | Experimental | Procedure: Pyloric restrictionEndoscopic method of pyloric restriction in order to decrease gastric emptying. The hypothesis is that this will cause and early and prolonged satiety which will inturn lead to decreased food consumption and lead to weight loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18- 65
- Male or female participants with a BMI >30 and < 45
- Female participants of childbearing age should not be pregnant, must have a negative serum or urine test and agree to use birth control for duration of the study.
- Participant did not undergo previous Roux-en-Y bypass with the gastric pouch limited to the cardia
Key exclusion criteria (21 listed)
- Allergic to eggs or egg products, wheat, Gluten or Prolamins.
- currently on life saving oral medications
- Participants allergic to Scopolamine
- Participants allergic to botulinum toxin
- Participants who are currently on oral medications for their serious 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 |
|---|---|---|
| Pyloric restrictionThe Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract. However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested. | Procedure or surgery | Pyloric restriction |
Primary outcome
Percent weight loss
Time frame: At 1, 3 and 6 months
The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: [(Baseline Weight - Final 6 month Weight)/Baseline Weight] x 100%.
5 secondary outcomes
Participant satisfaction
Time frame: At 6 months post procedure
Delay in gastric emptying
Time frame: From baseline to 4 weeks post procedure
Change in BMI
Time frame: At 1, 3 and 6 Months
Percentage of Responders
Time frame: At 1, 3 and 6 Months
Change in Medication Use.
Time frame: At 1, 3 and 6 Months
Results and safety
The study was stopped early (reason given: Suspended as we are looking for more durable method/device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Description and location of studyLink provided by the sponsor.
- 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.
Larry S Miller, 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?
A study testing Pyloric restriction in people with Obesity and Over Weight, 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 4 inclusion and 21 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 22 Feb 2019. 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: Suspended as we are looking for more durable method/device). 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?
Percent weight loss (time frame: At 1, 3 and 6 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 22 Feb 2019.