An observational study in Obesity, sponsored by University Hospital Ostrava. Completed at 4 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by University Hospital Ostrava · Observational
Among 97 studies in Obesity with a site in Czechia — 26 open to participants now, 46 under way, 32 of them phase 3. Obesity · Czechia.
Among the 97 studies in Obesity with a site in Czechia, this one is the only one that started in 2015, is one of 9 observational ones, and was the 22nd registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →26 of the 97 studies in Obesity with a site in Czechia are open now. Recruiting first, the newest first:
Ascletis Pharma (China) Co., Limited · Sites in Czechia, United States, Canada and 4 more countries
Ascletis Pharma (China) Co., Limited · Sites in Czechia, United States, Germany and 3 more countries
AstraZeneca · Sites in Czechia, United States, Argentina and 13 more countries
Novo Nordisk A/S · Sites in Czechia, United States, Argentina and 16 more countries
Novo Nordisk A/S · Sites in Czechia, United States, Argentina and 24 more countries
A study can be open while its sites in Czechia have not opened yet or have stopped. Only those recruiting at a site in Czechia →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
97 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 227 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Median enrollment 478 across the 88 interventional studies, 200 across the 9 observational. Of the 44 that completed or were terminated, 14 (32%) have results posted.
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68 of 97 have an industry lead sponsor. The 10 most frequent:
University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
University Hospital Ostrava has 5 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
16 of the studies in Obesity with a site in Czechia that are under way reach primary completion within a year, 13 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT06993792Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes | 2027-08 |
Among the 97 studies in Obesity with a site in Czechia, from their registry updates:
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Intragastric balloon degree of efficacy and duration of effect can be variable and unpredictable. The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing effect. The aim of the study was to determine the utility/efficacy and responder rate with the Spatz3 AIGB.
The results of the Spatz adjustable balloon system have been reported in four studies with weight losses of 24.4 kg (48.8% excess weight loss - EWL), 21.6 kg (45.7% EWL),17.2 kg (42.9% EWL) and 16.3 kg (67.4% EWL), respectively. The responder rate (>25% EWL) was 88.5% in one recent study.
The authors report and analyze the results of 227 Spatz3 patients retrospectively reviewed in 3 centers- some adjusted and some not adjusted during the course of their 1-year implantation - to determine if the adjustment option can improve overall results and diminish the non-responder rate.
The Spatz3 Adjustable intragastric balloon (IGB) (Spatz FGIA, Inc. New York, USA) was implanted at the following centers between May and December 2015: University Hospital, Ostrava, Czech Republic, Clinica Opcion Medica, Barcelona, Spain, and Optimal Clinic, Tel Aviv, Israel. Patients were selected according to the well-established criteria for intragastric balloon implantation, consistent with NIH and CE Mark guidelines, and were independently evaluated by members of the staff: gastroenterologists, dieticians, and psychologists. Indications for Spatz3 Adjustable IGB implantation included one of the following: (1) temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (>35) who refuse surgery or are at high risk for surgery, (2) temporary weight loss treatment for a patient without indications for surgery (BMI>29). All patients underwent upper gastrointestinal endoscopy using conscious sedation with or without an anesthetist using one or more of the following medications - Propofol, Midazolam, and Fentanyl.
Balloons were inflated with a mean 464ml (400-500ml) of normal saline with the addition of 2-3 ml of a 1% solution of Methylene Blue (not used in the Czech Republic center). Patients were recovered for 45 minutes and discharged the same day on a once-daily PPI, anti-nausea medications (Aprepitant 125 mg day 1; 80 mg days 2 and 3), ondansetron (8 mg Q6H X 3 days), anti-spasmodic (papaverine 80 mg tid prn), and dietary instructions. After the fifth post-procedure day, a progressive full liquid to soft to solid 1,200-1,400 kcal diet was started. Monthly follow up with dietician and/or doctor (gastroenterologist or endocrinologist) was offered to all patients after implantation. Cognitive behavioral therapy by licensed psychologists was offered in 2 of the 3 centers (206/227 patients) with 6-10 sessions after implantation. Patients who were intolerant to the balloon could be adjusted downward by 100-150 ml. Patients with one or more of the following were offered upward adjustments of the balloon volume (200-400 ml at the discretion of the endoscopist): weight loss plateau; lack of balloon effect; ability to overeat without resultant symptoms (any of the following: nausea, vomiting, bloating, eructation, abdominal pain, acid reflux symptoms). Preparation for an adjustment or extraction procedure required the following diet: 3 days prior- no meat or vegetables; 2 days prior- full liquids; 1 day prior- clear liquids and NPO after midnight. After 12 months of placement, the balloon was deflated by aspiration via standard balloon needle or deflation utilizing the valve, and extraction was completed using a grasping forceps or a polypectomy snare - all under conscious sedation.
Patients with a temporary weight loss treatment, with body mass index (BMI) in the range of bariatric surgery (>35) who refuse surgery or are at high risk for surgery or a temporary weight loss treatment without indications for surgery (BMI > 29).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with implanted Spatz3 AIGB balloon.
Device: Spatz3 AIGB
Implantation of Spatz3 AIGB balloon.
Weight loss
The achieved weight loss was recorded for the patients in the study.
Time frame: 8 months
Balloon intolerance
Intolerance of the intragastric balloon was recorded.
Time frame: 8 months
Plan to share: No — The authors have no plan make individual participant data available to other researchers.
Ran from May 2015 to primary completion in Dec 2015, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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