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NCT05007964
A Multi-Center Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)
NA trial testing Spatz4 Adjustable Balloon System in Overweight and Obesity in 66 participants. Completed in 29 August 2023.
29 August 2023
Quick facts
| Lead sponsor | Spatz FGIA, Inc |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 14 June 2022 |
| Primary completion | 29 August 2023 |
| Estimated completion | 29 August 2023 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Spatz4 Adjustable Balloon System
Conditions studied
- Overweight and Obesity — all drugs for Overweight and Obesity →
Sponsor
Spatz FGIA, Inc
Who can join
Adults 18 to 65, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. Up to 66 eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz4 balloon. All subjects will follow a calorie restricted diet designed by the dietician. An up adjustment will be performed at 16 weeks (±2 weeks). The subjects will be followed for 2 weeks after the up adjustment procedure, after which the study ends. Subjects will be given the option to continue the implantation period until 52 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05007964
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Spatz4 Adjustable Balloon System
Trials testing the same drug.
- NCT06373666 — A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). · NA · completed
Other recruiting trials for Overweight and Obesity
Currently open trials in the same condition.
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- NCT07313761 — A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered · Phase 1 · active not recruiting
- NCT07165431 — Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2). · NA · recruiting
Other Spatz FGIA, Inc trials
Trials by the same sponsor.
- NCT06373666 — A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). · NA · completed
- NCT05086302 — Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study · completed
- NCT04800835 — A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05007964 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spatz FGIA, Inc
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05007964.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing