ObesityNCT02872740
Gastric Arterial Embolization for Weight Loss
A study testing Embolization of Left Gastric Artery and Embolization of Gastroepiploic Artery in people with Obesity, run by University Health Network, Toronto.
Trial summary
Title: Embolization of Gastric Arterial Supply for Weight Loss Sample size: 10 patients Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Embolization of Left Gastric Artery and Embolization of Gastroepiploic Artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease
Who cannot join
- Basic
- Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment
- Gastrointestinal
- Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L
- Cardiovascular
- Known aortic pathology such as aneurysm or dissection Peripheral arterial disease
Show all 12Show fewer
- Renal
- Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2
- Hematologic/Immunologic/Oncologic/Infectious
- Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7
- Psychiatric
- Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia
About this study
Title: Embolization of Gastric Arterial Supply for Weight Loss
Sample size:
Read more
10 patients
Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery.
Study Design:
Single center, randomized, prospective, non-blinded pilot study.
Study Duration:
12 months (November 2015 - December 2015).
Agent:
150-250 micron polyvinyl alcohol particles
Primary objective:
To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients.
Primary objective measure:
The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.
- Conditions
- Obesity
- Being tested
- Embolization of Left Gastric Artery, Embolization of Gastroepiploic Artery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization of Left Gastric ArteryProcedure or surgery
Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
Embolization of Gastroepiploic ArteryProcedure or surgery
Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
| Study group | Role | What they receive |
|---|---|---|
| Embolization of Left Gastric Artery | Experimental | These patients will have their left gastric artery embolized Receives: Procedure: Embolization of Left Gastric Artery |
| Embolization of Gastroepiploic Artery | Experimental | These patients will have their gastroepiploic artery embolized Receives: Procedure: Embolization of Gastroepiploic Artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events
Measured: 1 year
Secondary outcomes (2)
Weight
weight change
Measured: 1 year
Cardiovascular risk factors
serum lipids, hemoglobin A1C, blood pressure, sleep apnea
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 posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
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 Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Simons, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872740
- Sponsor's protocol ID
- 15-9576
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Arterial Embolization for Weight Loss
- ClinicalTrials.gov ID
- NCT02872740
- Acronym / sponsor ID
- 15-9576
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Aug 2016 (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.
Title: Embolization of Gastric Arterial Supply for Weight Loss
Sample size:
10 patients
Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery.
Study Design:
Single center, randomized, prospective, non-blinded pilot study.
Study Duration:
12 months (November 2015 - December 2015).
Agent:
150-250 micron polyvinyl alcohol particles
Primary objective:
To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients.
Primary objective measure:
The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization of Left Gastric Artery | Experimental | Procedure: Embolization of Left Gastric ArteryThese patients will have their left gastric artery embolized |
| Embolization of Gastroepiploic Artery | Experimental | Procedure: Embolization of Gastroepiploic ArteryThese patients will have their gastroepiploic artery embolized |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease
Key exclusion criteria (12 listed)
- Basic
- Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment
- Gastrointestinal
- Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L
- Cardiovascular
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 |
|---|---|---|
| Embolization of Left Gastric ArteryLeft gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles | Procedure or surgery | Embolization of Left Gastric Artery |
| Embolization of Gastroepiploic ArteryGastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles | Procedure or surgery | Embolization of Gastroepiploic Artery |
Primary outcome
Adverse events
Time frame: 1 year
Adverse events
2 secondary outcomes
Weight
Time frame: 1 year
Cardiovascular risk factors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization of Left Gastric Artery and Embolization of Gastroepiploic Artery in people with Obesity, run by University Health Network, Toronto.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Adverse events (time frame: 1 year). 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 19 Aug 2016.