AzTrials
AzTrials

Arterial EmbolizationGETLEANNCT02248688

Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically

A study testing BeadBlock 300 - 500 Micron and Left Gastric Artery Embolization in people with Arterial Embolization and Other Surgical Procedures, run by Dayton Interventional Radiology 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
Search all trials

Trial summary

The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. Read more about this study

Who is it for?
Ages 22 to 65 yearsHealthy volunteers can take part
What is being tested?
BeadBlock 300 - 500 Micron and Left Gastric Artery Embolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Sep 2014to Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic table <400lbs due to table weight limits Appropriate anesthesia risk as determined by certified anesthesia provider evaluation preprocedure.
  • Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and also participate in the informed consent).
  • Subjects who have failed previous attempts at weight loss through diet, exercise, and behavior modification (as it is recommended that conservative options, such as supervised low calorie diets combined with behavior therapy and exercise, should be attempted prior to enrolling in this study).

Who cannot join

  • Less than 22 years of age Major surgery within the past eight weeks Previous gastric, pancreatic, hepatic and splenic surgery Previous radiation therapy to the left or right upper quadrant Previous gastric, hepatic, or splenic embolization Any history of portal venous hypertension Serum creatinine > 1.8 mg/dL History of kidney problems Pregnant or intend to become pregnant within one year History of severe bleeding disorder (platelet count less than 40,000) Allergy to materials in the embolic agents (acrylamido polyvinyl alcohol macromer) Enrolled in another study Any patient who has a history of allergic reaction to iodinated contrast Abnormal baseline gastric emptying study Patients taking anti-coagulants or antiplatelet drugs Patients currently taking or requiring chronic use of NSAID or steroid medications Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting Patients with any history of peptic ulcer disease Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities.
  • Patients with any contraindications for monitored anesthesia care or general surgery Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism Patients with active substance abuse or alcoholism Patients with defined noncompliance with previous medical care Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
  • Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.
  • Patients with hiatal hernia Patients with known aortic disease, such as dissection or aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dayton Interventional Radiology

    Dayton, Ohio, 45409

Other trials in United States

About this study

Official title: Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (GET LEAN)

The purpose of this pilot study is to achieve the collection of safety and efficacy data in patients undergoing left gastric artery embolization for morbid obesity in the United States. As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is not designed to achieve new indications for this device.

Read the detailed description

Beadblock will be used intraarterially to occlude in this case the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone ghrelin (one of the hormones responsible for appetite) is produced. Ghrelin is a 28 amino acid hunger stimulating peptide and hormone that is produced mainly by P/D1 cells lining the fundus of the stomach and epsilon cells of the pancreas. Ghrelin has emerged as the first identified circulating hunger hormone. Ghrelin is also the only known circulating orexigen, or appetite enhancing hormone.

Left gastric artery embolization may be a minimally invasive alternative to the current surgical treatment of gastric bypass or reduction surgery. These treatments have known serious complications including anastomotic leaks, bowel obstruction, paralytic ileus, deep vein thrombosis, pulmonary embolism, gastrointestinal bleeding, dumping syndrome, and anesthesia risks resulting in morbidity and mortality.

Literature review for gastric artery embolization

Transarterial embolization is a common interventional procedure used to treat a variety of medical conditions. In the image-guided procedure, an embolic, or obstructive, agent is inserted through a catheter and placed inside an artery to prevent blood flow in an artery or to a specific area of the body. Types of embolic agents include beads, coils, gel foam,as well as other materials and devices.

Gastric artery embolization has been used since the 1970's to treat life threatening gastric hemorrhage. This is commonly accepted as standard of care and has been life saving for thousands of patients. It is even deemed to be effective enough to be used empirically in the setting of angiographically negative life threatening hemorrhage (as a reflection of its safety margin).

Recent animal studies over the past several years in porcine and canine models have shown that gastric artery embolization results in the suppression of ghrelin levels and weight loss.

Arepally, et al. (2008) first described the technique of gastric artery embolization to reduce weight gain. In a controlled study, he used sodium morrhuate within a porcine model with resultant lower ghrelin levels and significantly blunted weight gain (in otherwise rapidly growing young swine).

Paxton, et al. (SIR abstract in 2012, later published in 2013 and 2014) described the technique of 40 micron microsphere particle embolization in a similar porcine model that also resulted in lowered ghrelin levels and reduced weight gain. Also noted there was no duodenal upregulation for ghrelin.

Bawudun et al. (2012) described a technique of left gastric embolization using mixture of bleomycin and lipiodol versus polyvinyl alcohol 500-700 micron particles to create weight loss in a canine model without gastric ulceration. In addition, he demonstrated significant reduction in subcutaneous fat and plasma ghrelin.

Kipshidze, et al. (2013) performed the first in man study reported at the annual meeting of the American College of Cardiology that showed an average of 45lbs of weight loss in 6 months and reduced ghrelin levels in 5 patients with no complications (with endoscopic follow-up) in this small series using BeadBlock 300-500 micron particles. According to personal correspondence with the author of this study the weight loss is sustained for at least 1 year with no complications in these 5 patients. He also noted that an additional 7 patients have been treated without complications.

A recent retrospective case control study presented at the 2013 Radiological Society of North American annual meeting found that there was an average of 7.9% decrease in body weight (at 3 months) in 15 patients who underwent left gastric artery embolization for life threatening hemorrhage compared to 1.2% (P=0.001) for age matched controls (who underwent embolization other than the left gastric artery for upper gastrointestinal bleeding).

Being tested
BeadBlock 300 - 500 Micron, Left Gastric Artery Embolization
Keywords
Bariatric Embolization, Gastric Artery Emboliziation, Left Gastric Artery Embolization, Morbid Obesity, Obesity, Weight Loss, Ghrelin, Embolization
Medical subject headings
Obesity, Obesity, Morbid, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BeadBlock 300 - 500 MicronDevice

    Also called GET LEAN

    Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.

  • Left Gastric Artery EmbolizationProcedure or surgery

Study groups in NCT02248688
Study groupRoleWhat they receive
Embolic Agent - BeadBlockOtherLeft Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
Receives: Device: BeadBlock 300 - 500 Micron; Procedure: Left Gastric Artery Embolization

What is being measured

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

  1. Body Weight Average 6 Months Post-Procedure

    The mean body weight of all 5 participants at 6-Months post-procedure.

    Measured: 6-Month

  2. Body Weight Average 12 Months Post-Procedure

    The mean body weight of all 5 participants at 12-Months post-procedure.

    Measured: 12-Month

  3. Change in Average Body Weight From Baseline at 6 Months Post-Procedure

    Average change in body weight lost.

    Calculated as the average of participants:

    (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

    Measured: Baseline, 6 Months

  4. Change in Average Body Weight From Baseline at 12 Months Post-Procedure

    Average change in body weight lost.

    Calculated as the average of participants:

    (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)

    Measured: Baseline, 12 Months

  5. Percentage of Excess Body Weight Loss at 6 Months Post-Procedure

    Calculated as the average of participants:

    (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

    Measured: Baseline, 6 Month

  6. Percentage of Excess Body Weight Loss at 12 Months Post-Procedure

    Calculated as the average of participants:

    (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))

    Measured: Baseline, 12 Month

  7. Average Ghrelin Hormone Levels at 6 Months Post-Procedure

    The mean of participant's 6-Month post-procedure Ghrelin levels.

    Measured: 6-Month

  8. Average Ghrelin Hormone Levels at 12 Months Post-Procedure

    The mean of participant's 12-Month post-procedure Ghrelin levels.

    Measured: 12-Month

  9. Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure

    Calculated as the average of participants:

    (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100

    Measured: 6-Month, Baseline

  10. Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure

    Calculated as the average of participants:

    (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) * 100

    Measured: 12-Month, Baseline

Secondary outcomes (18)

  1. Average Leptin Hormone Levels at 6 Months Post-Procedure

    The mean of participant's 6-month post-procedure Leptin levels.

    Measured: 6-Month

  2. Average Leptin Hormone Levels at 12 Months Post-Procedure

    The mean of participant's 12-month post-procedure Leptin levels.

    Measured: 12-Month

  3. Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure

    Calculated as the average of participants:

    (((6-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100

    Measured: 6-Month, Baseline

  4. Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure

    Calculated as the average of participants:

    (((12-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) * 100

    Measured: 12-Month, Baseline

  5. Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure

    The mean of participant's 6-month post-procedure CCK levels.

    Measured: 6-Month

  6. Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure

    The mean of participant's 12-month post-procedure CCK levels.

    Measured: 12-Month

  7. Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure

    Calculated as the average of participants:

    (((6-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100

    Measured: 6-Month, Baseline

  8. Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure

    Calculated as the average of participants:

    (((12-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) * 100

    Measured: 12-Month, Baseline

  9. Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure

    The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Measured: 6 Month

  10. Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure

    The mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants:

    (6-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)

    Measured: 6 Month, Baseline

  11. QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure

    The mean of participant's 12-month post-procedure Short Form-36 Version 2 Physical Component Scores, ranging from 0-100; higher scores indicate better health status.

    Measured: 12 Month

  12. Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure

    The mean of participant's SF-36 Version 2 PCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants:

    (12-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)

    Measured: 12 Month, Baseline

  13. QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure

    The mean of participant's SF-36 Version 2 MCS at 6-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Measured: 6 Month

  14. Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure

    The mean of participant's SF-36 Version 2 MCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants:

    (6-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)

    Measured: 6 Month, Baseline

  15. QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure

    The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Measured: 12 Month

  16. Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure

    The mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.

    Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants:

    (12-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)

    Measured: 12 Month, Baseline

  17. 6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels

    HgA1c Levels of diabetic patient 6-Months post-procedure.

    Measured: 6-Month

  18. 12-Month Post-Procedure HgA1c Levels

    HgA1c Levels of diabetic patient 12-Months post-procedure.

    Measured: 12-Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2019
  4. Study completionNov 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02248688
Sponsor's protocol ID
Q131650
Acronym
GETLEAN
Status last verified
Dec 2021
First submitted
23 Sep 2014
Last updated
25 Jan 2022
Data monitoring committee
Yes
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest left gastric artery embolization for the treatment of morbid obesity. Data shared will be coded, with no PHI included. Approval of the request and is a prerequisite to the sharing of data.

Publications

  • Rosch J, Dotter CT, Brown MJ. Selective arterial embolization. A new method for control of acute gastrointestinal bleeding. Radiology. 1972 Feb;102(2):303-6. doi: 10.1148/102.2.303. No abstract available.

    PubMed 4536688

  • Bookstein JJ, Chlosta EM, Foley D, Walter JF. Transcatheter hemostasis of gastrointestinal bleeding using modified autogenous clot. Radiology. 1974 Nov;113(2):277-85. doi: 10.1148/113.2.277. No abstract available.

    PubMed 4547597

  • Morris DC, Nichols DM, Connell DG, Burhenne HJ. Embolization of the left gastric artery in the absence of angiographic extravasation. Cardiovasc Intervent Radiol. 1986;9(4):195-8. doi: 10.1007/BF02577940.

    PubMed 3094950

  • Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.

    PubMed 18796671

  • Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.

    PubMed 24462005

  • Paxton BE, Kim CY, Alley CL, Crow JH, Balmadrid B, Keith CG, Kankotia RJ, Stinnett S, Arepally A. Bariatric embolization for suppression of the hunger hormone ghrelin in a porcine model. Radiology. 2013 Feb;266(2):471-9. doi: 10.1148/radiol.12120242. Epub 2012 Nov 30.

    PubMed 23204538

  • Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.

    PubMed 22367009

  • Brown KT, Friedman WN, Marks RA, Saddekni S. Gastric and hepatic infarction following embolization of the left gastric artery: case report. Radiology. 1989 Sep;172(3):731-2. doi: 10.1148/radiology.172.3.2788892.

    PubMed 2788892

  • Castaneda-Zuniga WR, Jauregui H, Rysavy J, Amplatz K. Selective transcatheter embolization of the upper gastrointestinal tract: an experimental study. Radiology. 1978 Apr;127(1):81-3. doi: 10.1148/127.1.81.

    PubMed 305577

  • Bradley EL 3rd, Goldman ML. Gastric infarction after therapeutic embolization. Surgery. 1976 Apr;79(4):421-4.

    PubMed 1083078

  • Prochaska JM, Flye MW, Johnsrude IS. Left gastric artery embolization for control of gastric bleeding: a complication. Radiology. 1973 Jun;107(3):521-2. doi: 10.1148/107.3.521. No abstract available.

    PubMed 4702528

  • Robbins SM, Tuten TU, Clements JL, Fekete P. Angiographic diagnosis of gastric volvulus with report of a complication following left gastric artery embolization. Gastrointest Radiol. 1988;13(2):112-4. doi: 10.1007/BF01889038.

    PubMed 3258835

  • Miller DL, Balter S, Cole PE, Lu HT, Schueler BA, Geisinger M, Berenstein A, Albert R, Georgia JD, Noonan PT, Cardella JF, St George J, Russell EJ, Malisch TW, Vogelzang RL, Miller GL 3rd, Anderson J; RAD-IR study. Radiation doses in interventional radiology procedures: the RAD-IR study: part I: overall measures of dose. J Vasc Interv Radiol. 2003 Jun;14(6):711-27. doi: 10.1097/01.rvi.0000079980.80153.4b.

    PubMed 12817038

  • Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.

    PubMed 27567998

Questions about this trial

What is this clinical trial studying?

A study testing BeadBlock 300 - 500 Micron and Left Gastric Artery Embolization in people with Arterial Embolization and Other Surgical Procedures, run by Dayton Interventional Radiology 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 4 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 25 Jan 2022. 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?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Weight Average 6 Months Post-Procedure (time frame: 6-Month). The study lists 10 primary outcomes in all. 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 NCT02248688, which also lists 14 linked publications.

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 25 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in