Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03598920
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2018-06-13
Brief Title:
Aspiration Therapy for Obese Adolescents
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interventional studies devoted to adolescents are relatively rare in the world This has several reasons Treatment and research on obesity are centered on advanced forms of obesity in adults bearing in mind that social and health problems make these patients cope with their condition Studies on children tend to focus on epidemiology On the other hand effective long-term effective treatment is not just for young adults and adolescents However appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease Here the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age
The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals that is population groups where according to the WHO and CDC Centers for Disease Control and Prevention there has been a rapid increase in the incidence of obesity especially during the last 20 years
The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals that is population groups where according to the WHO and CDC Centers for Disease Control and Prevention there has been a rapid increase in the incidence of obesity especially during the last 20 years
Detailed Description:
The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist which is currently used in the adult population The method has been approved by FDA since 2016 The method involves the introduction of percutaneous endoscopic gastrostomy PEG that allows the aspiration of a portion of the food and the control of the size and volume of the food received even in the unmanaged size and volume of food intake
Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava as In addition to a pediatric and internal examination a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis and will further assess the degree of patient support and co-operation Selected participants in the study or their family members will receive informed consent A study participant is considered to be a participant in the study after consent to his her inclusion in the study after the informed consent has been signed The AspireAssist aspiration device is the definitive participation in the study
Two parts will be monitored within the project 1 Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion especially in surgical methods 2 The second objective is to monitor the saccharide and lipid metabolism GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied
The patients enrolled in the study are followed for the period of twelve months
Timetable of the study procedures and controls
Preoperative examination
Demographic data on age sex weight height smoking
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 3 months postoperatively
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 6 months after surgery
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 12 months after surgery
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life
Statistical data processing for statistical evaluation descriptive statistics is used arithmetical average standard deflection frequency tables X2 test Fishers exact test analysis of variance ANOVA calculating of the OR odds ratio with 95 confidence intervals and logistic regression Statistical tests are evaluated at the significance level of 5 Statistical analysis is performed in the Stata 10 programme Program EpiData is used for data collection
Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava as In addition to a pediatric and internal examination a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis and will further assess the degree of patient support and co-operation Selected participants in the study or their family members will receive informed consent A study participant is considered to be a participant in the study after consent to his her inclusion in the study after the informed consent has been signed The AspireAssist aspiration device is the definitive participation in the study
Two parts will be monitored within the project 1 Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion especially in surgical methods 2 The second objective is to monitor the saccharide and lipid metabolism GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied
The patients enrolled in the study are followed for the period of twelve months
Timetable of the study procedures and controls
Preoperative examination
Demographic data on age sex weight height smoking
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 3 months postoperatively
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 6 months after surgery
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life Examination 12 months after surgery
Assessment of body composition and sampling of blood
Questionnaires for the quality of Life
Statistical data processing for statistical evaluation descriptive statistics is used arithmetical average standard deflection frequency tables X2 test Fishers exact test analysis of variance ANOVA calculating of the OR odds ratio with 95 confidence intervals and logistic regression Statistical tests are evaluated at the significance level of 5 Statistical analysis is performed in the Stata 10 programme Program EpiData is used for data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None