Obesity, MorbidSNAP-PSNCT05049824
Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy
A study testing Self Forming Magnetic (SFM) Anastomosis System in people with Obesity, Morbid, run by GI Windows, Inc. at 1 site in Spain.
Trial summary
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Self Forming Magnetic (SFM) Anastomosis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2021to 1 Oct 2024
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22-65 years at screening
- Body mass index (BMI) ≥35 and ≤50
- Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
- Weight stable over 3-month period
- Negative H. pylori breath test
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
- If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
- Able to understand and sign informed consent documents.
Who cannot join
- Known or suspected allergy to nickel or titanium or nitinol
- Contraindication to general anesthesia
- Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
- Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- Clinically significant findings during screening endoscopy at target region for compression anastomosis
- Uncontrolled hypertension
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- Pre-existing severe comorbid cardio-respiratory disease
- History of type 1 diabetes or poorly controlled type 2 diabetes
- Abnormal liver biochemistry
- History of chronic gastrointestinal disease
- Specific genetic or hormonal cause of obesity
- Recent tobacco/nicotine product cessation (within 3 months prior)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
Read the detailed description
Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.
- Conditions
- Obesity, Morbid
- Being tested
- Self Forming Magnetic (SFM) Anastomosis System
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Forming Magnetic (SFM) Anastomosis SystemDevice
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators
| Study group | Role | What they receive |
|---|---|---|
| SFM Treatment Arm | Experimental | The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion Receives: Device: Self Forming Magnetic (SFM) Anastomosis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
- Weight loss measured as a percent of total body weight (TBW)
Measured: 12 Months
Secondary outcomes (8)
Percent responders
Percent of subjects losing at least 10% and 20% of baseline weight from baseline
Measured: 12 Months
Excess weight loss
Mean change in Excess weight loss from baseline
Measured: 12 Months
Change in serum lipids
Mean change in serum lipids from baseline
Measured: 12 Months
Change in blood pressure
Mean change in blood pressure from baseline
Measured: 12 Months
Change in fasting glucose
Mean change in fasting glucose in subjects with T2DM at baseline
Measured: 12 Months
Change in HbA1c
Mean change in HbA1c in subjects with T2DM at baseline
Measured: 12 Months
Change in BMI
Mean change in BMI from baseline
Measured: 12 Months
Change in Absolute Weight Loss
Mean change in Absolute Weight Loss from baseline
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start26 Oct 2021
- Primary completion25 Jul 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Turro, MD, Principal investigator, Gastroenterologist at Teknon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049824
- Sponsor's protocol ID
- GIW 19-001
- Acronym
- SNAP-PS
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05049824
- Acronym / sponsor ID
- SNAP-PS / GIW 19-001
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 20 Sep 2021 (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.
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
Detailed description
Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SFM Treatment Arm | Experimental | Device: Self Forming Magnetic (SFM) Anastomosis SystemThe subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 22-65 years at screening
- Body mass index (BMI) ≥35 and ≤50
- Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
- Weight stable over 3-month period
- Negative H. pylori breath test
Key exclusion criteria (12 listed)
- Known or suspected allergy to nickel or titanium or nitinol
- Contraindication to general anesthesia
- Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
- Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- Clinically significant findings during screening endoscopy at target region for compression anastomosis
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 |
|---|---|---|
| Self Forming Magnetic (SFM) Anastomosis SystemThe SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators | Device | SFM Treatment Arm |
Primary outcome
Weight Loss
Time frame: 12 Months
1. Weight loss measured as a percent of total body weight (TBW)
8 secondary outcomes
Percent responders
Time frame: 12 Months
Excess weight loss
Time frame: 12 Months
Change in serum lipids
Time frame: 12 Months
Change in blood pressure
Time frame: 12 Months
Change in fasting glucose
Time frame: 12 Months
Change in HbA1c
Time frame: 12 Months
Change in BMI
Time frame: 12 Months
Change in Absolute Weight Loss
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
Roman Turro, MD principal investigator
Gastroenterologist at Teknon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Forming Magnetic (SFM) Anastomosis System in people with Obesity, Morbid, run by GI Windows, Inc. at 1 site in Spain.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 15 Oct 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 15 Oct 2024.