ObesityNCT02881684
Aspiration Therapy in Asian Patients
A study testing Aspiration Therapy (AspireAssist®) and Lifestyle Therapy in people with Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This research project will provide insight into the efficacy and safety of aspiration therapy in the management of obesity and its comorbidities in the Asian population, and will determine if there is a role for this novel endoscopic device in the treatment algorithm of obesity in the investigators' local regions. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Aspiration Therapy (AspireAssist®) and Lifestyle Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening.
- 21- 65 years of age (inclusive) at time of screening.
- Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs)
- Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening.
- Women of childbearing potential who agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, intrauterine device (IUD), condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit
- Willing and able to provide informed consent and comply with the protocol.
Who cannot join
- Evidence of an eating disorder or major depression
- History of gastrointestinal disease or previous gastric surgery that would increase the risk of the AspireAssist® Tube (A-Tube) placement
- Severe co-existing medical diseases or malignancies
- Bleeding tendency (low platelet, coagulopathy including being on anti-coagulants)
- Pregnant/lactating
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Michele MA Yuen, MBBS, (852) 6073 2211, micheleyuen@hotmail.com
Carol HY Fong, MSc Stat, (852) 2255 3711, kalofong@gmail.com
About this study
Official title: Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
This research project will provide insight into the efficacy and safety of aspiration therapy in the management of obesity and its comorbidities in the Asian population, and will determine if there is a role for this novel endoscopic device in the treatment algorithm of obesity in the investigators' local regions.
Read the detailed description
Obesity is a major global health problem and Asians are equally affected. According to the latest Behavioural Risk Factor Survey in 2014, 20.8% of adults in Hong Kong have body mass index (BMI) belonging to the obese category. Obesity is associated with a multitude of medical and psychological comorbidities that could cumulate in increased healthcare costs and impaired quality of life. As such, an effective treatment strategy for obesity is imperative.
Sustainable weight reduction by lifestyle measures alone is often difficult if not impossible. Pharmacotherapy can provide additional weight reduction when used as an adjunct to lifestyle intervention but the efficacy is modest. The most effective method for weight reduction to date is bariatric surgery but this is limited by its invasiveness and irreversibility. The limitations of current obesity treatment has led to an increased interest in endoscopic treatment, which may be more effective than pharmacotherapy and less invasive and more reversible than bariatric surgery.
The AspireAssist® Aspiration Therapy System is a novel endoscopic therapy developed by Aspire Bariatrics Inc. (King of Prussia, United States) for treatment of obesity. The system takes advantage of percutaneous endoscopic gastrostomy (PEG) tube technology to induce weight reduction by aspirating a portion of ingested meals from the stomach. In a pilot study involving 18 Caucasian obese subjects randomly assigned in a 2:1 ratio to aspiration therapy group and lifestyle therapy only group, the weight reduction was 18.6% +/- 2.3% and 5.9% +/- 5.0% respectively. The present study aims to investigate the effectiveness and safety of this device in Asian subjects.
- Conditions
- Obesity
- Being tested
- Aspiration Therapy (AspireAssist®), Lifestyle Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration Therapy (AspireAssist®)Device
Also called AspireAssist® Aspiration Therapy System
Use of the AspireAssist device in aspiration therapy
Lifestyle TherapyBehavioural
Also called Lifestyle Behavioral Therapy
Lifestyle therapy is a behavioral, diet and physical activity education program
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Intervention:
1. Device: Aspiration Therapy (AspireAssist)
- Subjects randomized to the treatment group will undergo an endoscopic procedure to have the experimental device (i.e. the A-tube) inserted. This will be followed by regular follow up visits and lifestyle therapy matched to the control group. The device will be removed at the end of one year and this group will be observed for one year more to determine if there is any legacy effect.
2. Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy Receives: Device: Aspiration Therapy (AspireAssist®); Behavioral: Lifestyle Therapy |
| Control | Active comparator | Intervention:
(1) Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy
- Subjects randomized to the control group will receive lifestyle management matched to the treatment group in the first year. At the end of one year, they will be crossed over to treatment and the A-tube will be inserted. They will then follow up the same follow up schedule of the treatment group during the first year. Receives: Device: Aspiration Therapy (AspireAssist®); Behavioral: Lifestyle Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction by aspiration therapy after 1 year of treatment
Aspiration therapy using the AspireAssist® Aspiration Therapy System (Aspire Bariatrics Inc., King of Prussia, United States) for weight reduction in Asian subjects with obesity over a 12-month treatment period.
Measured: 1 year
Secondary outcomes (23)
Change in blood pressure
mean percent change in systolic and diastolic blood pressures during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in Serum Lipids
mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in Mean Hemoglobin A1c
change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline) during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum leptin
change in mean serum leptin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum ghrelin
change in mean serum ghrelin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum peptide YY
change in mean serum peptide YY levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum gastric inhibitory polypeptide
change in mean serum gastric inhibitory polypeptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum glucagon-like peptide 1
change in mean serum glucagon-like peptide 1 levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum amylin
change in mean serum amylin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum pancreatic polypeptide
change in mean serum pancreatic polypeptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum cholecystokinin
change in mean serum cholecystokinin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum insulin
change in mean serum insulin levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum C-peptide
change in mean serum C-peptide levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in serum fibroblast growth factor 19
change in mean serum fibroblast growth factor 19 levels during treatment (aspiration therapy + lifestyle therapy) period compared to control (lifestyle therapy only) period, and in the AT group compared to the control group
Measured: 2 years
Change in perceived appetite / satiety
Using the control of eating questionnaire
Measured: 2 years
Change in depressive symptoms
Patient Health Questionnaire
Measured: 2 years
Change in anxiety symptoms
State-Trait Anxiety Inventory (STAI)
Measured: 2 years
Change in eating behavior
Eating Disorder Examination (EDE-Q)
Measured: 2 years
Change in psychosocial functioning
Obesity Related Psychological Problem Scale (OP Scale)
Measured: 2 years
Electrolyte disturbances
Number of treatment group subjects with hypokalemia, hypokalemia requiring oral replacement therapy and hypokalemia requiring in-patient care
Measured: 2 years
Micronutrient disturbances
Number of treatment group subjects with iron / vitamin B12 / folate deficiencies, with iron / vitamin B12 / folate deficiencies requiring oral replacement therapy and with iron / vitamin B12 / folate deficiencies requiring in-patient care
Measured: 2 years
Adverse events
The incidence of procedure-related, device-related, and therapy-related adverse events unrelated to electrolyte or micronutrient disturbances will be measured, as well as the incidence of device related, or unrelated, serious adverse events, including unanticipated adverse device effects. Also, the development of adverse eating behaviors will be assessed.
Measured: 2 years
Sustainability of weight reduction (if any) with removal of the A-tube after the treatment period
Mean weight gain during the first year after removal of the A-tube in the AT group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Aspire Bariatrics, Inc.
- Responsible party
- Principal investigator, Dr. Michele Yuen, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881684
- Sponsor's protocol ID
- UW 16-244
- Status last verified
- May 2018
- First submitted
- 12 Aug 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
PubMed 9875838Ko GT. The cost of obesity in Hong Kong. Obes Rev. 2008 Mar;9 Suppl 1:74-7. doi: 10.1111/j.1467-789X.2007.00442.x.
PubMed 18307703Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Mond JM, Hay PJ, Rodgers B, Owen C, Beumont PJ. Validity of the Eating Disorder Examination Questionnaire (EDE-Q) in screening for eating disorders in community samples. Behav Res Ther. 2004 May;42(5):551-67. doi: 10.1016/S0005-7967(03)00161-X.
PubMed 15033501Beumont PJ, Kopec-Schrader EM, Talbot P, Touyz SW. Measuring the specific psychopathology of eating disorder patients. Aust N Z J Psychiatry. 1993 Sep;27(3):506-11. doi: 10.3109/00048679309075810.
PubMed 8250797Karlsson J, Taft C, Sjostrom L, Torgerson JS, Sullivan M. Psychosocial functioning in the obese before and after weight reduction: construct validity and responsiveness of the Obesity-related Problems scale. Int J Obes Relat Metab Disord. 2003 May;27(5):617-30. doi: 10.1038/sj.ijo.0802272.
PubMed 12704406van Hout GC, van Oudheusden I, van Heck GL. Psychological profile of the morbidly obese. Obes Surg. 2004 May;14(5):579-88. doi: 10.1381/096089204323093336.
PubMed 15186623Herpertz S, Kielmann R, Wolf AM, Langkafel M, Senf W, Hebebrand J. Does obesity surgery improve psychosocial functioning? A systematic review. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1300-14. doi: 10.1038/sj.ijo.0802410.
PubMed 14574339Abiles V, Rodriguez-Ruiz S, Abiles J, Mellado C, Garcia A, Perez de la Cruz A, Fernandez-Santaella MC. Psychological characteristics of morbidly obese candidates for bariatric surgery. Obes Surg. 2010 Feb;20(2):161-7. doi: 10.1007/s11695-008-9726-1. Epub 2008 Oct 29.
PubMed 18958537Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013 Dec;145(6):1245-52.e1-5. doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.
PubMed 24012983Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
PubMed 25918644
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Reduction by Aspiration Therapy in Asian Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT02881684
- Acronym / sponsor ID
- UW 16-244
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Aspire Bariatrics, Inc.
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project will provide insight into the efficacy and safety of aspiration therapy in the management of obesity and its comorbidities in the Asian population, and will determine if there is a role for this novel endoscopic device in the treatment algorithm of obesity in the investigators' local regions.
Detailed description
Obesity is a major global health problem and Asians are equally affected. According to the latest Behavioural Risk Factor Survey in 2014, 20.8% of adults in Hong Kong have body mass index (BMI) belonging to the obese category. Obesity is associated with a multitude of medical and psychological comorbidities that could cumulate in increased healthcare costs and impaired quality of life. As such, an effective treatment strategy for obesity is imperative.
Sustainable weight reduction by lifestyle measures alone is often difficult if not impossible. Pharmacotherapy can provide additional weight reduction when used as an adjunct to lifestyle intervention but the efficacy is modest. The most effective method for weight reduction to date is bariatric surgery but this is limited by its invasiveness and irreversibility. The limitations of current obesity treatment has led to an increased interest in endoscopic treatment, which may be more effective than pharmacotherapy and less invasive and more reversible than bariatric surgery.
The AspireAssist® Aspiration Therapy System is a novel endoscopic therapy developed by Aspire Bariatrics Inc. (King of Prussia, United States) for treatment of obesity. The system takes advantage of percutaneous endoscopic gastrostomy (PEG) tube technology to induce weight reduction by aspirating a portion of ingested meals from the stomach. In a pilot study involving 18 Caucasian obese subjects randomly assigned in a 2:1 ratio to aspiration therapy group and lifestyle therapy only group, the weight reduction was 18.6% +/- 2.3% and 5.9% +/- 5.0% respectively. The present study aims to investigate the effectiveness and safety of this device in Asian subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Aspiration Therapy (AspireAssist®), Behavioral: Lifestyle TherapyIntervention: 1. Device: Aspiration Therapy (AspireAssist) - Subjects randomized to the treatment group will undergo an endoscopic procedure to have the experimental device (i.e. the A-tube) inserted. This will be followed by regular follow up visits and lifestyle therapy matched to the control group. The device will be removed at the end of one year and this group will be observed for one year more to determine if there is any legacy effect. 2. Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy |
| Control | Active comparator | Device: Aspiration Therapy (AspireAssist®), Behavioral: Lifestyle TherapyIntervention: (1) Behavioral: Lifestyle Therapy Lifestyle therapy is a behavioral, diet and physical activity education program Other Name: Lifestyle Behavioral Therapy - Subjects randomized to the control group will receive lifestyle management matched to the treatment group in the first year. At the end of one year, they will be crossed over to treatment and the A-tube will be inserted. They will then follow up the same follow up schedule of the treatment group during the first year. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Measured body mass index (BMI) of 27.5-55.0 kg/m2 at time of screening.
- 21- 65 years of age (inclusive) at time of screening.
- Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs)
- Stable weight (<3% change in self-reported weight) over the previous 3 months at time of screening.
- Women of childbearing potential who agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, intrauterine device (IUD), condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit
Key exclusion criteria (5 listed)
- Evidence of an eating disorder or major depression
- History of gastrointestinal disease or previous gastric surgery that would increase the risk of the AspireAssist® Tube (A-Tube) placement
- Severe co-existing medical diseases or malignancies
- Bleeding tendency (low platelet, coagulopathy including being on anti-coagulants)
- Pregnant/lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration Therapy (AspireAssist®)Also: AspireAssist® Aspiration Therapy SystemUse of the AspireAssist device in aspiration therapy | Device | Control, Treatment |
| Lifestyle TherapyAlso: Lifestyle Behavioral TherapyLifestyle therapy is a behavioral, diet and physical activity education program | Behavioural | Control, Treatment |
Primary outcome
Weight reduction by aspiration therapy after 1 year of treatment
Time frame: 1 year
Aspiration therapy using the AspireAssist® Aspiration Therapy System (Aspire Bariatrics Inc., King of Prussia, United States) for weight reduction in Asian subjects with obesity over a 12-month treatment period.
23 secondary outcomes
Change in blood pressure
Time frame: 2 years
Change in Serum Lipids
Time frame: 2 years
Change in Mean Hemoglobin A1c
Time frame: 2 years
Change in serum leptin
Time frame: 2 years
Change in serum ghrelin
Time frame: 2 years
Change in serum peptide YY
Time frame: 2 years
Change in serum gastric inhibitory polypeptide
Time frame: 2 years
Change in serum glucagon-like peptide 1
Time frame: 2 years
Change in serum amylin
Time frame: 2 years
Change in serum pancreatic polypeptide
Time frame: 2 years
Change in serum cholecystokinin
Time frame: 2 years
Change in serum insulin
Time frame: 2 years
Change in serum C-peptide
Time frame: 2 years
Change in serum fibroblast growth factor 19
Time frame: 2 years
Change in perceived appetite / satiety
Time frame: 2 years
Change in depressive symptoms
Time frame: 2 years
Change in anxiety symptoms
Time frame: 2 years
Change in eating behavior
Time frame: 2 years
Change in psychosocial functioning
Time frame: 2 years
Electrolyte disturbances
Time frame: 2 years
Micronutrient disturbances
Time frame: 2 years
Adverse events
Time frame: 2 years
Sustainability of weight reduction (if any) with removal of the A-tube after the treatment period
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Background: PubMed 9875838Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
- Background: PubMed 18307703Ko GT. The cost of obesity in Hong Kong. Obes Rev. 2008 Mar;9 Suppl 1:74-7. doi: 10.1111/j.1467-789X.2007.00442.x.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 15033501Mond JM, Hay PJ, Rodgers B, Owen C, Beumont PJ. Validity of the Eating Disorder Examination Questionnaire (EDE-Q) in screening for eating disorders in community samples. Behav Res Ther. 2004 May;42(5):551-67. doi: 10.1016/S0005-7967(03)00161-X.
- Background: PubMed 8250797Beumont PJ, Kopec-Schrader EM, Talbot P, Touyz SW. Measuring the specific psychopathology of eating disorder patients. Aust N Z J Psychiatry. 1993 Sep;27(3):506-11. doi: 10.3109/00048679309075810.
- Background: PubMed 12704406Karlsson J, Taft C, Sjostrom L, Torgerson JS, Sullivan M. Psychosocial functioning in the obese before and after weight reduction: construct validity and responsiveness of the Obesity-related Problems scale. Int J Obes Relat Metab Disord. 2003 May;27(5):617-30. doi: 10.1038/sj.ijo.0802272.
- Background: PubMed 15186623van Hout GC, van Oudheusden I, van Heck GL. Psychological profile of the morbidly obese. Obes Surg. 2004 May;14(5):579-88. doi: 10.1381/096089204323093336.
- Background: PubMed 14574339Herpertz S, Kielmann R, Wolf AM, Langkafel M, Senf W, Hebebrand J. Does obesity surgery improve psychosocial functioning? A systematic review. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1300-14. doi: 10.1038/sj.ijo.0802410.
- Background: PubMed 18958537Abiles V, Rodriguez-Ruiz S, Abiles J, Mellado C, Garcia A, Perez de la Cruz A, Fernandez-Santaella MC. Psychological characteristics of morbidly obese candidates for bariatric surgery. Obes Surg. 2010 Feb;20(2):161-7. doi: 10.1007/s11695-008-9726-1. Epub 2008 Oct 29.
- Results publication: PubMed 24012983Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013 Dec;145(6):1245-52.e1-5. doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.
- Results publication: PubMed 25918644Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
- Obesity. Centre for Health Protection, Department of Health, Government of Hong Kong, 2015.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration Therapy (AspireAssist®) and Lifestyle Therapy in people with Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele MA Yuen, MBBS ((852) 6073 2211, micheleyuen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight reduction by aspiration therapy after 1 year of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881684, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.