For Healthcare Professionals

For Healthcare Professionals

A non-invasive tool to support satiety perception in your practice

GASTER control® is a CE-marked abdominal support device integrating controlled extra-parietal compression. Prescribed, delivered by orthotists, and designed for integration into structured care pathways.

CE-marked medical device — Prescription only
01 — Clinical rationale

Why mechanical satiety matters

Satiety is driven by the integration of multiple signals — mechanical, neuro-hormonal, and behavioral. Among these, gastric distension and abdominal mechanosensitivity play a well-documented role in triggering fullness perception and regulating meal size.

Yet in many patients with overweight or obesity, the perception of these mechanical signals appears altered. Food intake regulation remains difficult despite nutritional guidance, and maintaining weight loss over time is a persistent challenge.

GASTER control® was designed to act specifically on this mechanical component — not to create satiety, but to modulate the conditions in which it is perceived.

The device does not create satiety. It applies controlled external abdominal compression to the epigastric region, targeting the mechanical component of satiety perception. This approach is grounded in established physiological principles of gastric mechanosensitivity.
02 — Mechanism of action

Extra-parietal abdominal compression

GASTER control® operates through controlled extra-parietal compression — an external, adjustable mechanical action applied to the epigastric area, without any contact with internal structures.

How it works across the meal cycle

Pre-meal (15–30 min before): Mechanical preparation of signal conditions, priming the perception of gastric volume.
During meals: Amplification of distension-related signals, supporting earlier recognition of fullness and spontaneous portion reduction.
Post-meal (20–40 min after): Maintenance of perceived satiety, limiting post-prandial snacking.

Non-invasive No pharmacological action Adjustable compression Reproducible positioning Reversible
03 — Clinical positioning

Where GASTER control® fits in the care pathway

GASTER control® is not a standalone treatment for overweight or obesity. It is positioned as a complementary, non-invasive tool designed to be integrated within a broader medical strategy — alongside nutritional guidance, behavioral support, physical activity, and, where appropriate, pharmacological or surgical approaches.

Bariatric surgery pathway

Pre-operative support for weight reduction before intervention. Post-operative management in cases of weight regain.

GLP-1 therapy transition

Support during dose reduction or after treatment discontinuation. Maintaining behavioral and sensory regulation of satiety.

First-line non-invasive option

Selected patients with BMI 27–30 not eligible for GLP-1 therapies. Patients experiencing difficulty with pharmacological approaches.

Behavioral consolidation

Supporting the transition from structured dietary intervention to autonomous eating behavior and long-term portion control.

GASTER control® is not an alternative to GLP-1 therapies or bariatric surgery. It is a complementary tool that may support regulation of food intake within existing care pathways, particularly in transition or consolidation phases.
04 — Exploratory clinical data

Initial observations in real-world conditions

A prospective exploratory feasibility observation was conducted in 11 participants with varied profiles (overweight, moderate obesity, post-bariatric, pharmacological backgrounds) over 8 weeks, with structured dietitian follow-up.

Exploratory feasibility observation — n=11, 8 weeks
91%
spontaneous portion reduction
81%
earlier satiety perception
3–6%
weight reduction observed
91%
improvement in eating behavior
These findings are exploratory and do not constitute proof of clinical efficacy. They are hypothesis-generating and currently under further evaluation in a multicentric observational registry.

Key observations from initial participants

Physiological: Earlier perception of fullness, reduced tolerance to large meals, mechanical satiety effect reported by over 80% of users — including during periods without active device use.

Behavioral: Disruption of automatic eating patterns, reduction in emotional and sugar-related snacking, educational effect on portion size and eating speed.

Tolerance: Good to very good overall. No serious adverse events reported. Reduced effectiveness observed in severe obesity (BMI > 40) due to morphological constraints.

05 — Ongoing clinical evaluation

Multicentric observational registry

A prospective multicentric observational registry (GC-REG-01) is currently underway, designed to document the use of GASTER control® in routine medical practice.

Study design

Type: Prospective observational registry, multicentric.
Population: Adults ≥18 years, BMI ≥25 and <40 kg/m².
Target enrollment: ~50 participants (initial milestone), extending up to 200 as the registry develops.
Duration: 8-week observation period (3 phases: progressive use, consolidation, autonomous separation).
Primary endpoint: Intra-individual variation in body weight between baseline (J0) and end of observation (S8).

Secondary endpoints

Anthropometric evolution (BMI, waist circumference), eating behavior modifications, device adherence, tolerance and adverse events, quality of life, and exploratory analysis of trajectories according to GLP-1 treatment status.

Data infrastructure

Data are pseudonymized and centralized on the Obeli platform, hosted on a certified Health Data Hosting (HDS) infrastructure, with full GDPR compliance.

Scientific governance

Dr Marius Nedelcu
Coordinating investigator — Bariatric surgeon
Dr Ludivine Muzard
Nutritionist
Dr Antoine Sina
Bariatric surgeon
Dr Anthony Rouers
Bariatric surgeon
Dr Gianfranco Calandra
Bariatric surgeon
Pr Ibrahim Dagher
Investigating physician
06 — Patient selection & safety

Appropriate patient profiles and contraindications

Recommended patient profiles

Based on initial observations, the following profiles appear to respond most consistently: adults with overweight or moderate obesity (BMI 25–40), patients in post-dietary or post-pharmacological phases (including post-GLP-1), patients in pre- or post-bariatric surgery pathways, and individuals with disorganized eating behaviors (excluding severe eating disorders).

Conditions for optimal use

Structured dietetic follow-up or behavioral coaching. Regular daily use before meals. Proper morphological fit (size selection, inflation guidance). Supportive care in patients with emotional or compulsive eating patterns.

Contraindications (refer to full Instructions for Use)
  • Pregnancy
  • Patients under 18 years of age
  • Morbid obesity (BMI > 40)
  • Irreducible or non-fitted abdominal hernia
  • Immediate post-operative period without medical advice
  • Severe gastro-esophageal reflux, gastric ulcer, or active digestive pathology
  • Cardio-respiratory or neurological conditions aggravated by abdominal compression
  • Diagnosed eating disorders
  • Dermatoses or skin lesions in the belt area
  • Any condition potentially worsened by abdominal compression

Possible side effects: Abdominal discomfort, mild respiratory constraint, skin redness or irritation, gastric reflux in sensitive individuals. The device should be removed immediately in case of pain, dyspnea, nausea, or dizziness.

07 — Practical information

Prescription, distribution, and sizing

Regulatory status

GASTER control® is classified as an abdominal support orthosis (CSA). CE-marked medical device. Distributed on medical prescription. In France: delivered by orthotists and pharmacists within the defined indication framework.

Available sizes

Size Circumference Balloon capacity Max pumps
Size 1 75 – 95 cm 0.75 L ~35
Size 2 95 – 115 cm 0.95 L ~45
Size 3 115 – 145 cm 1.15 L ~55

Maximum pump capacity is a safety specification, not a usage target. Adjustment should be guided by patient sensation — comfortable, perceptible, never painful.

Distribution partner (France)

Exclusive distribution by Lipoline, through orthotists and pharmacists. Structured training materials are available for prescribers and dispensers.

08 — Scientific foundation

Supporting scientific literature

The rationale underlying GASTER control® draws on established research in gastric mechanosensitivity, vagal afferent signaling, and the role of abdominal pressure in food intake regulation.

[1] Geliebter A, Westreich S, Gage D. Extra-abdominal pressure alters food intake, intragastric pressure, and gastric emptying rate. Am J Physiol. 1986;250(4 Pt 2):R549-52.
[2] Phillips RJ, Powley TL. Gastric volume detection after selective vagotomies in rats. Am J Physiol. 1998;274(6):R1626-38.
[3] Bai L, Mesgarzadeh S, Ramesh KS, et al. Genetic identification of vagal sensory neurons that control feeding. Cell. 2019;179(5):1129-1143.e23.
[4] Paintal AS. A study of gastric stretch receptors. Their role in the peripheral mechanism of satiation of hunger and thirst. J Physiol (Lond). 1954;126:255-270.

Interested in integrating GASTER control® into your practice?

Request detailed clinical documentation, training materials, or discuss patient eligibility with our medical team.

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This page is intended for healthcare professionals only. The information provided does not constitute medical advice. Clinical data presented are exploratory and should not be interpreted as established clinical performance. GASTER control® is a complementary tool designed for integration into structured care pathways under medical supervision. Always refer to the full Instructions for Use for contraindications, precautions, and usage guidance.
GASTER control® — GASTER Technology Limited, 5/1 Merchants Street, Valletta VLT 1171, Malta. Proprietary biomechanical design (patent pending).