Obesity, MorbidLOSEITNCT03185949

The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial

A study testing Endobar Infusion Catheter System and Behavioral therapy in people with Obesity, Morbid, run by Endobar Solutions LLC at 1 site in Czechia.

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

To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment of obesity before continuing to a larger Pivotal Trial. Investigational Device The investigational device in this clinical study is the Endobar Infusion Catheter System - a disposable system consisting of an occlusion… Read more about this study

Who is it for?: Ages 21 to 66 years
Conditions the study is for: Obesity, Morbid
What is being tested?: Endobar Infusion Catheter System and Behavioral therapy
Type of treatment: Injection or infusion, Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteCzechia
Study dates: 8 Feb 2017to 1 Dec 2018
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 21 to 66 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• BMI 35.0-50.0 kg/m2 at time of screening
Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.
Willing and able to provide informed consent

Who cannot join

• Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery
History of duodenal or gastric ulcers or regularly taking medications (therapy >1 day per week) that can cause ulcers (e.g., non-steroidal anti-inflammatory drugs)
Prior radiation to the upper abdomen
Prior embolization to the stomach, spleen or liver
Portal venous hypertension
Active H. pylori infection

Show all 29Show fewer

Uncontrolled hypertension (> 160/100 with or without medication).
Diabetes (determined by medical history, fasting blood glucose or results of an oral glucose tolerance test)
Serum triglyceride > 400 mg/dL at screening.
Class 4 or 5 surgical risk based on standard ASA criteria (Saklad M. Grading of patients for surgical procedures. Anesthesiol. 1941; 2:281-4).
Severe pulmonary or cardiovascular disease defined as a history or evidence of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome, coronary revascularization, heart failure requiring medications, history of sudden cardiac death, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
Class III: patients with marked limitation of activity; they are comfortable only at rest.
Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5 at screening).
Anemia (Hb < 10.0 g/dL) at screening.
Malignancy in the last 5 years (except for non-melanoma skin cancer).
Evidence of other significant organ system dysfunction (e.g. cirrhosis, renal failure)
Pregnant or lactating.
History of substance abuse in last 3 years.
Thyroid Stimulating Hormone (TSH) >2.0 x upper limit of normal at screening.
Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 5 years.
Taking diuretic medication for congestive heart failure or edema.
Evidence of significant mucosal inflammation, ulceration or ischemia detected on endoscopy, and those with unsuitable left gastric anatomy as judged by the study site physician will be excluded
Psychiatric illness that could affect compliance with the study, as judged by the site principle investigator.
Unable to complete screening requirements (compliance with visits and dietary record)
Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
Chronic abdominal pain that would potentially complicate management.
Unstable weight (>3% change; self-reported) over the previous 2 months at time of screening.
Subjects whom the site investigator, research team, or the study medical monitor feel is not able to participate in the study for any reason, including poor general health or unable/unwilling to follow the study protocol.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

OB klinika a.s., Pod Krejcárkem 975
Praha 3 - Žižkov, 130 00

Other trials in Czechia

About this study

Official title: Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People With Obesity

To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment of obesity before continuing to a larger Pivotal Trial.

Investigational Device The investigational device in this clinical study is the Endobar Infusion Catheter System - a disposable system consisting of an occlusion balloon catheter, a Smart Manifold delivery system.

Study Design/Planned Number of Subjects This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months.

Study Duration The duration of the study is expected to last approximately 18 months from the first enrollment . An additional 12 months to the study closeout after the last follow-up.

Read the detailed description

STUDY OBJECTIVES Objective The objective of this study is to conduct a sham controlled randomized trial to evaluate the efficacy and safety of the Endobar System for the treatment of obesity. Efficacy, Safety, and secondary outcomes will be evaluated at 6 and 12 months to allow expansion of the investigation into a larger, pivotal clinical study.

Study Design This is a prospective randomized, single blind, active treatment and sham controlled, single-center trial . After the informed consent and screening process are completed, all subjects who are eligible and wish to participate in the study will undergo baseline testing. Those who complete baseline testing will be randomized to either Endobar Therapy (ET) or Sham Treatment (ST) for 52 weeks. Both groups will be given lifestyle therapy for weight loss, which involves treatment with a behavioral education weight loss program delivered as 19 individual sessions in person over 52 weeks. Endobar Therapy involves catheter-based embolization of the left gastric artery. After 26 weeks, the ET group will continue to be monitored for an addition 26 weeks and the ST subjects will be given ET and monitored for 26 weeks. The duration of the entire study will be 52 weeks.

Conditions: Obesity, Morbid
Being tested: Endobar Infusion Catheter System, Behavioral therapy
Keywords: Obesity, Embolization, Left Gastric Artery
Medical subject headings: Obesity, Morbid, Obesity

What participants receive

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

Endobar Infusion Catheter SystemDevice
Bariatric embolization with microspheres using Endobar Infusion Catheter System
Behavioral therapyBehavioural
Healthy diet and exercise

Study groups in NCT03185949
Study group	Role	What they receive
Sedation and subcutaneous lidocaine	Sham comparator	Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Receives: Device: Endobar Infusion Catheter System; Behavioral: Behavioral therapy
interventional: bariatric embolization	Experimental	• In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Receives: Device: Endobar Infusion Catheter System; Behavioral: Behavioral therapy

What is being measured

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

Weight Loss
1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference.
2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).
Measured: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Adverse Events
The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.
Measured: 12 months post-randomization
Absolute Weight Loss (kg)
6-month change: The absolute difference in the initial and 6-month weight (kg) (i.e., initial - 6 month weight). These changes were averaged for each group and compared between the two groups to assess whether there was a meaningful difference.
12-month change: The absolute difference in the initial and 12-month weight (kg) (i.e., initial - 12 month weight).
Measured: 6 months post-procedure/sham and 12 months post-procedure

Secondary outcomes (4)

Percent Excess Body Weight (%EBWL) Loss
Percent excess body weight loss (% EBWL) is calculated by dividing the absolute weight loss divided by baseline excess weight and multiplying by 100% (i.e., excess weight / initial weight x 100%). Excess weight is defined as the difference between current weight and ideal weight.
%EBWL was calculated for the following time points:
1. 6 months: absolute weight loss was the difference from baseline to 6 months. %EBWL was averaged for each group and compared to assess whether there was a meaningful difference between the groups.
2. 12 months: absolute weight loss was the difference from baseline to 12 months.
Note, excess weight was determined from ideal body weights based on a BMI=25 kg/m2.
Measured: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Weight Loss ≥5%
Proportion of subjects who achieve ≥5% total body weight loss from baseline vs. those who do not
Measured: 6 months post-procedure/sham
6 Month Change in Lipids
6-month change (from baseline) in lipids for both groups. Unit of Measure: mg/dL
Measured: 6 months post-procedure/sham
6 and 12 Month Change in Blood Pressure
Change in absolute blood pressure levels from baseline to 6 months for both groups and baseline to 12 months for the initial treatment group.
Unit of Measure: mmHg
Measured: 6 months post-procedure/sham and 12 months post-procedure

Timeline

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

8 Feb 20171 Dec 2018

First posted14 Jun 2017
Study start8 Feb 2017
Primary completion1 Dec 2018
Study completion1 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Crossover
Model description: This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03185949
Sponsor's protocol ID: ESC-14-001
Acronym: LOSEIT
Status last verified: Sep 2022
First submitted: 9 May 2017
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Reddy VY, Neuzil P, Musikantow D, Sramkova P, Rosen R, Kipshidze N, Kipshidze N, Fried M. Transcatheter Bariatric Embolotherapy for Weight Reduction in Obesity. J Am Coll Cardiol. 2020 Nov 17;76(20):2305-2317. doi: 10.1016/j.jacc.2020.09.550.
PubMed 33183504

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People With Obesity
ClinicalTrials.gov ID: NCT03185949
Acronym / sponsor ID: LOSEIT / ESC-14-001
Conditions: Obesity, Morbid
Keywords: Obesity, Embolization, Left Gastric Artery
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Endobar Solutions LLCIndustry (pharma, biotech, devices)
Collaborators: OB KLINIKA a.s. Pod Krejcárkem 975 Praha 3 - Žižkov Tel.: +420 255 725 110, Na Homolce Hospital, High Tech Med Consult
Study start: 8 Feb 2017 (actual)
Primary completion: 1 Dec 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 14 Jun 2017 (actual)
Results: Posted 28 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment of obesity before continuing to a larger Pivotal Trial.

Study Duration The duration of the study is expected to last approximately 18 months from the first enrollment . An additional 12 months to the study closeout after the last follow-up.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months

Arm	Type	Receives
Sedation and subcutaneous lidocaine	Sham comparator	Device: Endobar Infusion Catheter System, Behavioral: Behavioral therapyLidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization.
interventional: bariatric embolization	Experimental	Device: Endobar Infusion Catheter System, Behavioral: Behavioral therapy• In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy

Who may qualify

Ages: 21 to 66 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

• BMI 35.0-50.0 kg/m2 at time of screening

Key exclusion criteria (29 listed)

• Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery

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
Endobar Infusion Catheter SystemBariatric embolization with microspheres using Endobar Infusion Catheter System	Device	Sedation and subcutaneous lidocaine, interventional: bariatric embolization
Behavioral therapyHealthy diet and exercise	Behavioural	Sedation and subcutaneous lidocaine, interventional: bariatric embolization

Primary outcome

Weight Loss
Time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference. 2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).
Number of Patients With Adverse Events
Time frame: 12 months post-randomization
The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.
Absolute Weight Loss (kg)
Time frame: 6 months post-procedure/sham and 12 months post-procedure
6-month change: The absolute difference in the initial and 6-month weight (kg) (i.e., initial - 6 month weight). These changes were averaged for each group and compared between the two groups to assess whether there was a meaningful difference. 12-month change: The absolute difference in the initial and 12-month weight (kg) (i.e., initial - 12 month weight).

4 secondary outcomes

Percent Excess Body Weight (%EBWL) Loss
Time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
Number of Patients With Weight Loss ≥5%
Time frame: 6 months post-procedure/sham
6 Month Change in Lipids
Time frame: 6 months post-procedure/sham
6 and 12 Month Change in Blood Pressure
Time frame: 6 months post-procedure/sham and 12 months post-procedure

Results and safety

Results posted to the registry on 28 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Control	22	18
Percutaneous Transcatheter Embolotherapy	22	19

Primary outcome: Weight Loss

Time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure. Mean (95% Confidence Interval). Unit: Percent change

Measure	Sham Control n = 18	Percutaneous Transcatheter Embolotherapy n = 19
6 Months: ITT Population	2.8 (0.9 to 4.7)	6.4 (3.2 to 9.6)
6 Months: PP Population	1.8 (0.5 to 3.0)	8.3 (4.9 to 11.6)
12 Months: ITT Population	–	6.5 (3.0 to 10.0)
12 Months: PP Population	–	9.3 (5.3 to 13.3)

Population analysed: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

Primary outcome: Number of Patients With Adverse Events

Time frame: 12 months post-randomization. Number. Unit: participants

Measure	Sham Control n = 20	Percutaneous Transcatheter Embolotherapy n = 34
Asymptomatic Ulcers	0	5
Epigastring Pain	3	4
Epigastric Pressure	0	3
Nausea	4	7
Vomitting	5	7

Population analysed: Safety Population (i.e. any participant who consented to be in the study and underwent either the sham or therapy procedure). Each count indicates a participant who reported experiencing the described event.

Primary outcome: Absolute Weight Loss (kg)

Time frame: 6 months post-procedure/sham and 12 months post-procedure. Mean (95% Confidence Interval). Unit: kilograms

Measure	Sham Control n = 18	Percutaneous Transcatheter Embolotherapy n = 19
6 Months: ITT Population	3.0 (0.9 to 5.0)	7.4 (3.8 to 11.0)
6 Months: PP Population	9.4 (5.6 to 13.2)	1.9 (0.5 to 3.3)
12 Months: ITT	–	7.8 (3.6 to 12.0)
12 Months: PP	–	9.3 (4.9 to 13.8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1) 12 Months for those initially randomized to PTE (therapy group); 2) 6 months for those initially randomized to sham group; 3) 6 months for those who crossed over to PTE (therapy group) after unblinding point of the study, pursuant to the study protocol.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Percutaneous Transcatheter Embolotherapy	1 of 34 (2.9%)	5 of 34 (14.7%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33183504Reddy VY, Neuzil P, Musikantow D, Sramkova P, Rosen R, Kipshidze N, Kipshidze N, Fried M. Transcatheter Bariatric Embolotherapy for Weight Reduction in Obesity. J Am Coll Cardiol. 2020 Nov 17;76(20):2305-2317. doi: 10.1016/j.jacc.2020.09.550.
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.

Martin Fried, MD principal investigator

OB klinika a.s., Prague, Czech Republic

Peter Neuzil, MD principal investigator

Na Homolce Hospital, Prague, Czech Republic

Vivek Reddy, MD principal investigator

Mount Sinai Medical Center, New York, NY, USA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Endobar Infusion Catheter System and Behavioral therapy in people with Obesity, Morbid, run by Endobar Solutions LLC at 1 site in Czechia.

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 29 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 28 Sep 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 Czechia. 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. Some participants in this study may receive a placebo. 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 28 Sep 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?

Weight Loss (time frame: 1) 6 months post-procedure/sham and 2) 12 months post-procedure). The study lists 3 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 NCT03185949, which also lists 1 linked publication.

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 28 Sep 2022.