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ObesityNCT02802007

Pilot Trial of the Elipse™ Intragastric Balloon System for the Treatment of Overweight and Obese Individuals

A study testing Elipse Intragastric Balloon in people with Obesity and Overweight, run by Allurion Technologies at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, non-randomized, open trial to be conducted in overweight and obese individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric Balloon System for the treatment of overweight and obese individuals. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Elipse Intragastric Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesin 2 countries
Study dates
Aug 2014to Jul 2016
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patient, female or male, 18 to 64 years of age.
  • Patient must be able to understand and be willing to sign an IC document.
  • Patient must be willing to participate in all aspects of the trial for the duration of the trial.
  • Patient must be motivated to lose weight and have realistic expectations.
  • Patient must complete the screening requirement to complete one week of Daily Eating Diaries and Daily Weight Logs.
  • Patient must pass the Screening Behavioral Interview.
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  • Patient must understand that even though they undergo the Elipse™ Treatment, they must follow the physician guidelines for eating behaviors and lifestyle modifications for weight loss.
  • Patient has a BMI of ≥ 27.0.
  • Females must be willing to use contraception throughout the course of the trial until they exit.
  • Patients must have a primary care physician that follows them for any co-morbid conditions.
  • Patients must live within 160 kilometers of the trial site and not plan to move out of the vicinity for the trial duration.
  • Patients must be fully ambulatory without any chronic orthopedic disease or reliance on crutches, walkers or a wheelchair that could preclude exercise during the trial.
  • Patient must have a stable home environment that is supportive of the patient's efforts to lose weight.
  • If Patient is an ex-smoker, they must be an ex-smoker for more than a year.
  • Patient agrees to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty.

Who cannot join

  • Patient has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  • Patient has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
  • Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to surgery), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
  • Patient has had previous bariatric or gastric surgery.
  • Patient has a history of acute pancreatitis.
  • Patient has a history of small bowel obstructions.
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  • Patients with a history of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to the Elipse™ Treatment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy. (For example: if a patient has had 2 cesarean sections, or one cesarean section and a laparoscopic appendectomy they would be excluded. If a patient had one cesarean section they may be included.)
  • Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias >2 centimeter (cm), inflammatory diseases, cancer, and varices.
  • Patient has a specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or PraderWilli syndrome.
  • Patient has poorly controlled diabetes.
  • Patient has renal and/or hepatic insufficiency.
  • Patient has systemic infection or abscess at the site to be treated.
  • Patient is undergoing chronic steroid therapy.
  • Patient is undergoing immunosuppressive therapy.
  • Patient is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
  • Patient is unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to treatment and continuing for 14 days post-treatment.
  • Patient has a history of pulmonary embolism or blood coagulation disorders.
  • Patient is unable to discontinue either prescription or over the counter weight loss medications at least 30 days prior to treatment and continuing for the remainder of the trial
  • Patient has cardiac pacemaker or other electric implantable device.
  • Patient has a history of using any tobacco products including but not limited to cigars, cigarettes, and pipes within 12 months prior to enrollment.
  • Patient has poorly controlled psychiatric disease such as depression.
  • Patient has eating disorders including night eating syndrome (NES), Bulimia, or binge eating disorder, or who continuously graze on food for the majority of the day.
  • Patient has uncontrolled life stressors at baseline such as divorce, or illness/death of personal acquaintances.
  • Patient currently uses or has a history of illicit drug use or excessive alcohol use.
  • Patient has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this trial, and does not agree to abstain from participation in other clinical trials of any kind during this trial.
  • Patient is not of sufficient medical health as determined by the PI to participate in the trial.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Czechia1 site

  • Ostrava University Hospital

    Ostrava

Other trials in Czechia

Greece1 site

  • Iatriko Palaiou Faliro

    Athens

Other trials in Greece

About this study

This is a prospective, non-randomized, open trial to be conducted in overweight and obese individuals. The primary objective is to evaluate the safety of the Elipse™ Intragastric Balloon System for the treatment of overweight and obese individuals. The secondary objective is to collect efficacy and device performance information to assist with future trial design and device iterations.

Conditions
Obesity, Overweight
Being tested
Elipse Intragastric Balloon
Medical subject headings
Obesity, Overweight

What participants receive

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

  • Elipse Intragastric BalloonDevice

Study groups in NCT02802007
Study groupRoleWhat they receive
Elipse Intragastric BalloonExperimentalPatients seeking weight loss received the Elipse Intragastric Balloon.
Receives: Device: Elipse Intragastric Balloon

What is being measured

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

  1. The occurrence and frequency of adverse events (AE)s, adverse device effects (ADE)s, serious adverse events (SAE)s, serious adverse device effects (SADE)s and unanticipated serious adverse device effects (USADE)s.

    Measured: 4 months

Secondary outcomes (3)

  1. Change in weight: Percent Excess Weight Loss (%EWL)

    Measured: 4 months

  2. Change in weight: Total Body Weight Loss (kg)

    Measured: 4 months

  3. Change in weight: Percent Total Body Weight Loss (%TBWL)

    Measured: 4 months

Timeline

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

  1. First posted16 Jun 2016 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2016 (estimated)

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02802007
Sponsor's protocol ID
TRL-1000-0001-B
Status last verified
Jun 2016
First submitted
12 Apr 2016
Last updated
16 Jun 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Elipse Intragastric Balloon in people with Obesity and Overweight, run by Allurion Technologies at 2 sites in 2 countries.

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 15 inclusion and 26 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Greece. 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?

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?

The occurrence and frequency of adverse events (AE)s, adverse device effects (ADE)s, serious adverse events (SAE)s, serious adverse device effects (SADE)s and unanticipated serious adverse device effects (USADE)s. (time frame: 4 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 NCT02802007.

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 16 Jun 2016.

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