The objective of this study is to evaluate the safety of the PlenSat Digestible Balloons.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duration of survival of the balloon inside the stomach is the main outcome of
this study. Furthermore, a safety analysis will assess the occurrence of
adverse events (AEs), serious adverse device effects (SADEs) and serious
adverse events (SAE), monitored from the moment of ingestion of the capsule up
to two weeks after observed digestion. Self-reported scores on symptoms of
reflux and dyspepsia will complement the safety analysis.
Secondary outcome
not applicable
Background summary
Obesity and obesity-associated comorbidities remain a major threat for Western
populations. Throughout the past decades, several different treatments
modalities have been established: lifestyle interventions and/or pharmaceutical
approaches for overweight patients (BMI 25-29.9 kg/m2) and surgical
interventions for the severe obese (BMI *40 kg/m2 or 35 kg/m2 in the presence
of comorbidity). Patients suffering from class I obesity (BMI 30-34.9 kg/m2) or
class II (BMI *35 kg/m2 without presence of comorbidity) are rarely considered
for surgery and often fail to maintain weight losses accomplished by lifestyle
interventions. For this specific patient population, there is a need for a safe
and more effective therapy. It is hypothesised that intragastric balloons can
provide a surrogate stomach fill, inducing an increase of satiety sensation and
therefore a decrease in food intake.
Study objective
The objective of this study is to evaluate the safety of the PlenSat Digestible
Balloons.
Study design
This is a single-centre feasibility study to test the safety of digestible
balloons in the treatment of adults with obesity. Subjects providing informed
consent and meeting all study eligibility criteria will be enrolled in this
prospective study. Baseline assessments for study eligibility will occur within
30 days prior to the procedure. Subjects will digest a single capsule, which
will inflate to a digestible balloon after encountering the acidic gastric
environment. After approximately three weeks the balloon will be *naturally*
digested by the gastrointestinal system. Study visits will be carried out
weekly during the entire duration of the study until the balloon is fully
digested and secreted in the faeces.
Intervention
The subjects enrolled in the study will ingest a single capsule under
supervision of the medical team of investigators. The balloon will contain a
radio-opaque tracer visible on X-ray. Weekly X-rays will be performed to
monitor balloon location and evaluate final digestion and secretion of the
balloon.
Study burden and risks
Each subject will swallow one single capsule. Per weekly site visit, each
subject will undergo a short, general physical examination and will be asked to
fill out the Gastrointestinal Symptom Rating Scale (GSRS). In addition, an
X-ray of the abdomen will be carried out every weekly visit until the device is
eliminated from the body. It is expected that each subject will visit the site
3 to 4 times after ingestion until the balloon is fully digested and the
materials have left the body.
P Debyelaan 25
Maastricht 6229HX
NL
P Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
18-80 years of age
Able and willing to sign an informed consent document
BMI of 30-39.9 kg/m^2
Sufficient and stable medical health
Must have a primary care physician
Exclusion criteria
Signs/symptoms of gastroduodenal ulcer disease (in history or present)
Poorly controlled diabetes or diabetes >10yr
Signs/symptoms of oesophageal or gastric disease (in history or present)
Signs/symptoms of dysmotility of gastrointestinal tract
Use of opioid drugs (past six weeks or present)
Female subject is pregnant or suspected to be pregnant, or lactating
Previous bariatric, gastric or oesophageal surgery
Swallowing disorders
Illicit drug use or alcohol abuse
Participation in other clinical study within past 4 weeks
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63462.068.17 |