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Obesity, MorbidNCT05064722

Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve

A study testing Self Forming Magnets (SFM) in people with Obesity, Morbid, run by GI Windows, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who… Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Obesity, Morbid
What is being tested?
Self Forming Magnets (SFM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
8 Nov 2021to 9 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 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 22-65 years at screening
  • Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 with at least one obesity related comorbidity or ≥ 40 but ≤ 50 kg/m2 with or without comorbidities at time of screening.
  • For SNAP-PS Cohort, subject should be at least 18 months from the initial sleeve gastrectomy and have failed to achieve at minimum 50% EWL
  • If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
  • Able to understand and sign informed consent document
  • Patient lives, and intends to remain, within a 300-km radius of study center for 24 months
  • Willing to refrain from smoking during the study follow-up period
  • If subject is female, she must commit to not becoming pregnant for 24 months and agree to use of contraceptives during this period and may not be nursing

Who cannot join

  • Type 1 Diabetes
  • Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
  • Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
  • Contraindication to general anesthesia
  • Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
  • Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
Show all 16Show fewer
  • Presence of a duodenal diverticulum (>10mm)
  • Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy for SNAP-PS cohort), pancreas or right colon
  • History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatory bowel disease) that in the opinion of the Investigator may preclude safe and complete study participation
  • Uncontrolled severe hypertension (blood pressure >160/100mmHg)
  • Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heart failure, uncontrolled cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease requiring supplemental oxygen, pulmonary embolism, MI with prior 6 months)
  • Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
  • Uncorrectable coagulation disorder (platelets < 100,000, PT >2 seconds above control or INR >1.5) at time of procedure, Note: management of anti-platelet medications, when applicable, will follow standard practices of the institution
  • Uncorrectable anemia (Hemoglobin < 11 g/dL in women and <12.5 g/dL in men)
  • Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome
  • For females of child-bearing potential: Pregnancy or desire to be pregnant during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bariatric Medicine Institute

    Salt Lake City, Utah, 84102

Other trials in United States

About this study

Official title: Initial Safety and Device Functionality of the Self-Forming Magnetic Anastomosis Device to Create a Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve (SNAP-S) or Those With Inadequate Weight Loss After Sleeve (SNAP-PS)

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

Read the detailed description

This is a single-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a D-I diversion in participants undergoing primary sleeve gastrectomy (SNAP-S cohort) or who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL at least 18 months post sleeve gastrectomy. Five patients will be enrolled in each cohort. Adult male and female subjects between the ages of 22 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation.

Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician).

Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a dual-path enteral diversion using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of a side-by-side anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I Diversion (SNAP-S cohort) it is anticipated that the D-I diversion will be created first followed by the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject).

Conditions
Obesity, Morbid
Being tested
Self Forming Magnets (SFM)
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 Magnets (SFM)Device

    To create the duodenal-ileal diversion, the duodenal magnet will be placed transorally in the proximal duodenum and the distal magnet will be placed in the ileum. Magnets are coupled and a compression induced anastomosis is created.

Study groups in NCT05064722
Study groupRoleWhat they receive
SNAP-SExperimentalCreation of a D-I diversion in participants undergoing primary sleeve gastrectomy (SNAP-S cohort)
Receives: Device: Self Forming Magnets (SFM)
SNAP-PSExperimentalCreation of a D-I diversion in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort)
Receives: Device: Self Forming Magnets (SFM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Loss

    Total Body Weight Loss from baseline

    Measured: 12 months

Secondary outcomes (5)

  1. Percent Responders

    Percent of patients losing at least 10% of their baseline weight

    Measured: 12 Months

  2. %EWL

    Mean Excess Weight Loss from baseline

    Measured: 12 Months

  3. Serum lipids

    Mean change of serum lipids from baseline

    Measured: 12 Months

  4. Systolic/diastolic blood pressure

    Mean percent change in systolic/diastolic blood pressure from baseline

    Measured: 12 Months

  5. Hemoglobin A1c

    Mean change of hemoglobin A1c (in patients with Type 2 Diabetes (T2DM) 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.

  1. First posted1 Oct 2021
  2. Study start8 Nov 2021
  3. Primary completion15 Apr 2024
  4. Study completion9 Oct 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064722
Sponsor's protocol ID
GIW 21-001
Status last verified
Jun 2024
First submitted
22 Sep 2021
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self Forming Magnets (SFM) in people with Obesity, Morbid, run by GI Windows, Inc. 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 8 inclusion and 16 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 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 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?

On the ClinicalTrials.gov record for NCT05064722.

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.

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