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NCT05017636: ESWT
Effect of Shock Wave Therapy Without Biological and Immuno-histochemical Analysis.
NA trial testing shock wave therapy in Obesity in 10 participants. Completed in 28 October 2019.
28 March 2019
Quick facts
| Lead sponsor | Indústria Brasileira Equipamentos Médicos - IBRAMED |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 10 |
| Start date | 7 January 2018 |
| Primary completion | 28 March 2019 |
| Estimated completion | 28 October 2019 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- shock wave therapy
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
Who can join
Adults 18 to 60, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Informative Summary: Extracorporeal shockwave therapy (ESWT) is a new method for treating aesthetic disorders within the field of aesthetic medicine, its mechanisms of action and physiological effects promise to combat localized fat accumulation, improve skin appearance, favor neocolagenesis and neovascularization. There are currently few studies on ESWT that can claim this benefit, but therapy has been shown to be safe and does not generate adverse reactions to individuals. Objective: To evaluate the physiological effects and mechanisms of ESWT acting on subcutaneous adipose tissue and adjacent structures through an experimental study. Methods: A randomized experimental clinical study will be performed in 30 women with grade I, II and III obesity who participated in the multidisciplinary preoperative preparation group for bariatric surgery with previously scheduled surgery. Participants will receive ESWT application within hours of surgery, or in the weeks prior to bariatric surgery, during the surgical procedure a small sample of subcutaneous adipose tissue will be taken for histological and immunohistochemical analysis. Hypotheses: Through histological and immunohistochemical analysis of the subcutaneous adipose tissue sample, the investigators can identify which real physiological effect and mechanism of action the ESWT has on subcutaneous adipose tissue, epidermis and adjacent structures, thus confirming the benefits of therapy. Statistical analysis: A descriptive analysis of the results obtained in the histological analysis will be performed initially, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between groups and session number, the analysis of variance (ANOVA) will be used for repeated measures. For comparison between groups the Tukey test will be used. The significance level adopted for the statistical tests will be 5% or p \<0.05.
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 NCT05017636
- Europe PMC full search
- ASCO Meeting Library
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Currently open trials in the same condition.
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- NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting
Other Indústria Brasileira Equipamentos Médicos - IBRAMED trials
Trials by the same sponsor.
- NCT06541899 — Safety and Efficacy of Cryolipolysis Clinical Protocols · Phase 4 · completed
- NCT05012514 — Effects of Led Photobiomodulation Therapy · NA · completed
- NCT05020054 — Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study · NA · completed
- NCT03312946 — Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite. · NA · unknown
- NCT03199781 — Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy · NA · unknown
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 NCT05017636 (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 Indústria Brasileira Equipamentos Médicos - IBRAMED
- Last refreshed: 24 August 2021
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/NCT05017636.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing