ObesityNCT05864911
Efficacy and Safety of the Gastric Bypass Stent System on Body Weight and Metabolic Parameters in Obese Patients
A study testing the Gastric Bypass Stent System in people with Obesity, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
In this study, the investigators use a novel endoscopic duodenal-jejunal bypass liner-the Gastric Bypass Stent System (Hangzhou Tangji Medical Technology Co., Ltd., China) for the treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- the Gastric Bypass Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2021to 3 Oct 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 and ≤60 years;
- Body mass index ( BMI) ≥30 kg/m2;
- American Society of Anesthesiologists( ASA) Physical Status Classification System:I-II.
Who cannot join
- Weight loss of more than 4.5 kg in the past three months, or taking weight-lowering drugs in the past month;
- Taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet drugs or anticoagulant therapy in the past month;
- Previous diagnosis with type 1 diabetes mellitus;
- Loss of islet β-cell function, C-peptide ≤ 1/2 of the normal low limit, or low C-peptide release curve under glucose load;
- Iron deficiency or iron deficiency anemia;
- Severe organ dysfunction of the heart, the lung, the liver or the kidney;
Show all 14Show fewer
- Patients who have undergone endoscopic retrograde cholangiopancreatography, or have a history of cholecystitis, gallstones with clinical symptoms or stones larger than 20 mm in diameter; pancreatitis or hepatic abscess;
- History of duodenal ulcer or gastric ulcer;
- Patients with gastrointestinal bleeding or potential bleeding;
- Digestive tract malformation, such as digestive tract atresia or previous gastrointestinal surgery that could cause failure of implantation or affect functioning of the device;
- History of intestinal obstruction in the past year;
- Thyroid dysfunction;
- History of systemic lupus erythematosus or scleroderma;
- Pregnant women or women desiring pregnancy in the next few months.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators use a novel endoscopic duodenal-jejunal bypass liner-the Gastric Bypass Stent System (Hangzhou Tangji Medical Technology Co., Ltd., China) for the treatment of obesity. The aim of this study is to evaluate the efficacy and safety of this new device on weight loss and obesity-associated metabolic parameters.
Read the detailed description
This is a prospective, open-label, single-arm study conducted at the department of gastroenterology, Beijing Friendship Hospital, Capital Medical University in China. In this study, all the participants were implanted with the Gastric Bypass Stent System. The device had an intended implantation time of 12 weeks, and the participants were followed up for 24 weeks. Both the implantation and explantation were conducted under general anesthesia. A liquid diet was required for a week after implantation to reduce the risk of early obstruction or migration. All the participants received an oral proton pump inhibitor twice daily during the implantation and within 4 weeks of removal. Primary outcomes were changes in excess weight loss and total weight loss at 12 and 24 weeks. Secondary outcomes included changes in body weight, body mass index (BMI), insulin resistance, liver enzymes, lipids and uric acid at 12 and 24 weeks, and device safety. At the first visit, baseline demographics, medical history, physical examination and laboratory tests were collected. The subjects were scheduled for follow-up visit at 1, 4, 12, 16 and 24 weeks. At each visit, body weight was measured and symptoms were recorded. Blood and fecal samples were collected to observe the changes of metabolic parameters and also to monitor the adverse effects. A complete blood count, liver function, blood glucose, insulin, HbA1C, lipids, uric acid, amylase, iron tests and fecal occult blood were partially or all measured at each visit. Insulin resistance was assessed by the homeostasis model assessment of insulin resistance (HOMA-IR), a value ≧2.69 was considered as insulin resistance. Elevated ALT or AST was considered as abnormal liver enzymes. Primary outcomes were changes in EWL and TWL at 12 and 24 weeks. Secondary outcomes included changes in body weight, BMI, insulin resistance, liver enzymes, lipids, UA at 12 and 24 weeks, and device safety.Analyses were conducted with IBM SPSS Statistics for Windows, version 22.0 (IBM Corporation , Armonk, NY). Data was reported as mean ± standard deviation (SD) . A p value of <0.05 was considered statistically significant. Analyses of body weight changes between different time points were conducted with a paired sample t test. Analyses of metabolic parameters in the blood were calculated by generalized estimating equations (GEE) because of the existence of missing values.
- Conditions
- Obesity
- Being tested
- the Gastric Bypass Stent System
- Keywords
- The Gastric Bypass Stent System, total weight loss, excess weight loss, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Gastric Bypass Stent SystemDevice
The Gastric Bypass Stent System is a newly designed endoscopic duodenal-jejunal bypass liner for the treatment of obesity by Hangzhou Tangji Medical Technology Co., Ltd.. It consists of three main parts: a 60-cm polyethylene sleeve fixed into the duodenal bulb by anchors with barbs, a delivery system and a retrieval system. Compared to the Endobarrier, it has several technical adjustments. First, it improved sleeve materials to provide better barrier properties and reduce the breeding of bacteria resulting in hepatic abscess. Second, the barbs on the anchoring system have been modified to reduce duodenal injury. Third, the delivery and retrieval system have been optimized to eliminate the need of fluoroscopic guidance during implantation and explantation.
| Study group | Role | What they receive |
|---|---|---|
| the Gastric Bypass Stent System group | Experimental | all the participants were implanted with the Gastric Bypass Stent System for 12 weeks and followed up for 24 weeks. Receives: Device: the Gastric Bypass Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline excess weight loss at 4 weeks
excess weight loss change
Measured: 4 weeks
Change from baseline excess weight loss at 12 weeks
excess weight loss change
Measured: 12 weeks
Change from baseline excess weight loss at 24 weeks
excess weight loss change
Measured: 24 weeks
Change from baseline total weight loss at 4 weeks
total weight loss change
Measured: 4 weeks
Change from baseline total weight loss at 12 weeks
total weight loss change
Measured: 12 weeks
Change from baseline total weight loss at 24 weeks
total weight loss change
Measured: 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events to assess device safety
Measured: within 24 weeks
Secondary outcomes (30)
Change from baseline body weight at 4 weeks
body weight change
Measured: 4 weeks
Change from baseline body weight at 12 weeks
body weight change
Measured: 12 weeks
Change from baseline body weight at 24 weeks
body weight change
Measured: 24 weeks
Change from baseline body mass index at 4 weeks
body mass index change
Measured: 4 weeks
Change from baseline body mass index at 12 weeks
body mass index change
Measured: 12 weeks
Change from baseline body mass index at 24 weeks
body mass index change
Measured: 24 weeks
Value change of homeostasis model assessment of insulin resistance at 4 weeks compared with baseline
the homeostasis model assessment of insulin resistance were calculated by [fasting insulin level (uU/mL)]×[fasting glucose level (mmol/L)]/22.5
Measured: 4 weeks
Value change of homeostasis model assessment of insulin resistance at 12 weeks compared with baseline
the homeostasis model assessment of insulin resistance were calculated by [fasting insulin level (uU/mL)]×[fasting glucose level (mmol/L)]/22.5
Measured: 12 weeks
Value change of homeostasis model assessment of insulin resistance at 24 weeks compared with baseline
the homeostasis model assessment of insulin resistance were calculated by [fasting insulin level (uU/mL)]×[fasting glucose level (mmol/L)]/22.5
Measured: 24 weeks
Value change of alanine aminotransferase at 4 weeks compared with baseline
value change of alanine aminotransferase
Measured: 4 weeks
Value change of alanine aminotransferase at 12 weeks compared with baseline
value change of alanine aminotransferase
Measured: 12 weeks
Value change of alanine aminotransferase at 24 weeks compared with baseline
value change of alanine aminotransferase
Measured: 24 weeks
Value change of aspartate aminotransferase at 4 weeks compared with baseline
value change of aspartate aminotransferase
Measured: 4 weeks
Value change of aspartate aminotransferase at 12 weeks compared with baseline
value change of aspartate aminotransferase
Measured: 12 weeks
Value change of aspartate aminotransferase at 24 weeks compared with baseline
value change of aspartate aminotransferase
Measured: 24 weeks
Value change of total cholesterol at 4 weeks compared with baseline
value change of total cholesterol
Measured: 4 weeks
Value change of total cholesterol at 12 weeks compared with baseline
value change of total cholesterol
Measured: 12 weeks
Value change of total cholesterol at 24 weeks compared with baseline
value change of total cholesterol
Measured: 24 weeks
Value change of low density lipoprotein cholesterol at 4 weeks compared with baseline
value change of low density lipoprotein cholesterol
Measured: 4 weeks
Value change of low density lipoprotein cholesterol at 12 weeks compared with baseline
value change of low density lipoprotein cholesterol
Measured: 12 weeks
Value change of low density lipoprotein cholesterol at 24 weeks compared with baseline
value change of low density lipoprotein cholesterol
Measured: 24 weeks
Value change of high density lipoprotein cholesterol at 4 weeks compared with baseline
value change of high density lipoprotein cholesterol
Measured: 4 weeks
Value change of high density lipoprotein cholesterol at 12 weeks compared with baseline
value change of high density lipoprotein cholesterol
Measured: 12 weeks
Value change of high density lipoprotein cholesterol at 24 weeks compared with baseline
value change of high density lipoprotein cholesterol
Measured: 24 weeks
Value change of triglyceride at 4 weeks compared with baseline
value change of triglyceride
Measured: 4 weeks
Value change of triglyceride at 12 weeks compared with baseline
value change of triglyceride
Measured: 12 weeks
Value change of triglyceride at 24 weeks compared with baseline
value change of triglyceride
Measured: 24 weeks
Value change of blood uric acid at 4 weeks compared with baseline
value change of blood uric acid
Measured: 4 weeks
Value change of blood uric acid at 12 weeks compared with baseline
value change of blood uric acid
Measured: 12 weeks
Value change of blood uric acid at 24 weeks compared with baseline
value change of blood uric acid
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start11 Mar 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- placement of the Gastric Bypass Stent System
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Tangji Medical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864911
- Sponsor's protocol ID
- BeijingFH20230327
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The baseline demographics, the body weight changes，blood and fecal tests at each visit and the adverse effects will be available.
Publications
Wang L, Zhou B, Zhao Z, Yang L, Zhang M, Jiang Y, Li Y, Zhou M, Wang L, Huang Z, Zhang X, Zhao L, Yu D, Li C, Ezzati M, Chen Z, Wu J, Ding G, Li X. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004-18. Lancet. 2021 Jul 3;398(10294):53-63. doi: 10.1016/S0140-6736(21)00798-4.
PubMed 34217401India State-Level Disease Burden Initiative CVD Collaborators. The changing patterns of cardiovascular diseases and their risk factors in the states of India: the Global Burden of Disease Study 1990-2016. Lancet Glob Health. 2018 Dec;6(12):e1339-e1351. doi: 10.1016/S2214-109X(18)30407-8. Epub 2018 Sep 12.
PubMed 30219317Ren M, Zhou X, Yu M, Cao Y, Xu C, Yu C, Ji F. Prospective study of a new endoscopic duodenal-jejunal bypass sleeve in obese patients with nonalcoholic fatty liver disease (with video). Dig Endosc. 2023 Jan;35(1):58-66. doi: 10.1111/den.14409. Epub 2022 Aug 23.
PubMed 35869797
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Gastric Bypass Stent System on Body Weight and Metabolic Parameters in Obese Patients
- ClinicalTrials.gov ID
- NCT05864911
- Acronym / sponsor ID
- BeijingFH20230327
- Conditions
- Obesity
- Keywords
- The Gastric Bypass Stent System, total weight loss, excess weight loss, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Tangji Medical Technology Co., Ltd.
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 18 May 2023 (actual)
- 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.
In this study, the investigators use a novel endoscopic duodenal-jejunal bypass liner-the Gastric Bypass Stent System (Hangzhou Tangji Medical Technology Co., Ltd., China) for the treatment of obesity. The aim of this study is to evaluate the efficacy and safety of this new device on weight loss and obesity-associated metabolic parameters.
Detailed description
This is a prospective, open-label, single-arm study conducted at the department of gastroenterology, Beijing Friendship Hospital, Capital Medical University in China. In this study, all the participants were implanted with the Gastric Bypass Stent System. The device had an intended implantation time of 12 weeks, and the participants were followed up for 24 weeks. Both the implantation and explantation were conducted under general anesthesia. A liquid diet was required for a week after implantation to reduce the risk of early obstruction or migration. All the participants received an oral proton pump inhibitor twice daily during the implantation and within 4 weeks of removal. Primary outcomes were changes in excess weight loss and total weight loss at 12 and 24 weeks. Secondary outcomes included changes in body weight, body mass index (BMI), insulin resistance, liver enzymes, lipids and uric acid at 12 and 24 weeks, and device safety. At the first visit, baseline demographics, medical history, physical examination and laboratory tests were collected. The subjects were scheduled for follow-up visit at 1, 4, 12, 16 and 24 weeks. At each visit, body weight was measured and symptoms were recorded. Blood and fecal samples were collected to observe the changes of metabolic parameters and also to monitor the adverse effects. A complete blood count, liver function, blood glucose, insulin, HbA1C, lipids, uric acid, amylase, iron tests and fecal occult blood were partially or all measured at each visit. Insulin resistance was assessed by the homeostasis model assessment of insulin resistance (HOMA-IR), a value ≧2.69 was considered as insulin resistance. Elevated ALT or AST was considered as abnormal liver enzymes. Primary outcomes were changes in EWL and TWL at 12 and 24 weeks. Secondary outcomes included changes in body weight, BMI, insulin resistance, liver enzymes, lipids, UA at 12 and 24 weeks, and device safety.Analyses were conducted with IBM SPSS Statistics for Windows, version 22.0 (IBM Corporation , Armonk, NY). Data was reported as mean ± standard deviation (SD) . A p value of <0.05 was considered statistically significant. Analyses of body weight changes between different time points were conducted with a paired sample t test. Analyses of metabolic parameters in the blood were calculated by generalized estimating equations (GEE) because of the existence of missing values.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- placement of the Gastric Bypass Stent System
| Arm | Type | Receives |
|---|---|---|
| the Gastric Bypass Stent System group | Experimental | Device: the Gastric Bypass Stent Systemall the participants were implanted with the Gastric Bypass Stent System for 12 weeks and followed up for 24 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥18 and ≤60 years;
- Body mass index ( BMI) ≥30 kg/m2;
- American Society of Anesthesiologists( ASA) Physical Status Classification System:I-II.
Key exclusion criteria (14 listed)
- Weight loss of more than 4.5 kg in the past three months, or taking weight-lowering drugs in the past month;
- Taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet drugs or anticoagulant therapy in the past month;
- Previous diagnosis with type 1 diabetes mellitus;
- Loss of islet β-cell function, C-peptide ≤ 1/2 of the normal low limit, or low C-peptide release curve under glucose load;
- Iron deficiency or iron deficiency anemia;
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 |
|---|---|---|
| the Gastric Bypass Stent SystemThe Gastric Bypass Stent System is a newly designed endoscopic duodenal-jejunal bypass liner for the treatment of obesity by Hangzhou Tangji Medical Technology Co., Ltd.. It consists of three main parts: a 60-cm polyethylene sleeve fixed into the duodenal bulb by anchors with barbs, a delivery system and a retrieval system. Compared to the Endobarrier, it has several technical adjustments. First, it improved sleeve materials to provide better barrier properties and reduce the breeding of bacteria resulting in hepatic abscess. Second, the barbs on the anchoring system have been modified to reduce duodenal injury. Third, the delivery and retrieval system have been optimized to eliminate the need of fluoroscopic guidance during implantation and explantation. | Device | the Gastric Bypass Stent System group |
Primary outcome
Change from baseline excess weight loss at 4 weeks
Time frame: 4 weeks
excess weight loss change
Change from baseline excess weight loss at 12 weeks
Time frame: 12 weeks
excess weight loss change
Change from baseline excess weight loss at 24 weeks
Time frame: 24 weeks
excess weight loss change
Change from baseline total weight loss at 4 weeks
Time frame: 4 weeks
total weight loss change
Change from baseline total weight loss at 12 weeks
Time frame: 12 weeks
total weight loss change
Change from baseline total weight loss at 24 weeks
Time frame: 24 weeks
total weight loss change
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: within 24 weeks
Number of participants with treatment-related adverse events to assess device safety
30 secondary outcomes
Change from baseline body weight at 4 weeks
Time frame: 4 weeks
Change from baseline body weight at 12 weeks
Time frame: 12 weeks
Change from baseline body weight at 24 weeks
Time frame: 24 weeks
Change from baseline body mass index at 4 weeks
Time frame: 4 weeks
Change from baseline body mass index at 12 weeks
Time frame: 12 weeks
Change from baseline body mass index at 24 weeks
Time frame: 24 weeks
Value change of homeostasis model assessment of insulin resistance at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of homeostasis model assessment of insulin resistance at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of homeostasis model assessment of insulin resistance at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of alanine aminotransferase at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of alanine aminotransferase at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of alanine aminotransferase at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of aspartate aminotransferase at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of aspartate aminotransferase at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of aspartate aminotransferase at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of total cholesterol at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of total cholesterol at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of total cholesterol at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of low density lipoprotein cholesterol at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of low density lipoprotein cholesterol at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of low density lipoprotein cholesterol at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of high density lipoprotein cholesterol at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of high density lipoprotein cholesterol at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of high density lipoprotein cholesterol at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of triglyceride at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of triglyceride at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of triglyceride at 24 weeks compared with baseline
Time frame: 24 weeks
Value change of blood uric acid at 4 weeks compared with baseline
Time frame: 4 weeks
Value change of blood uric acid at 12 weeks compared with baseline
Time frame: 12 weeks
Value change of blood uric acid at 24 weeks compared with baseline
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 34217401Wang L, Zhou B, Zhao Z, Yang L, Zhang M, Jiang Y, Li Y, Zhou M, Wang L, Huang Z, Zhang X, Zhao L, Yu D, Li C, Ezzati M, Chen Z, Wu J, Ding G, Li X. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004-18. Lancet. 2021 Jul 3;398(10294):53-63. doi: 10.1016/S0140-6736(21)00798-4.
- Background: PubMed 30219317India State-Level Disease Burden Initiative CVD Collaborators. The changing patterns of cardiovascular diseases and their risk factors in the states of India: the Global Burden of Disease Study 1990-2016. Lancet Glob Health. 2018 Dec;6(12):e1339-e1351. doi: 10.1016/S2214-109X(18)30407-8. Epub 2018 Sep 12.
- Background: PubMed 35869797Ren M, Zhou X, Yu M, Cao Y, Xu C, Yu C, Ji F. Prospective study of a new endoscopic duodenal-jejunal bypass sleeve in obese patients with nonalcoholic fatty liver disease (with video). Dig Endosc. 2023 Jan;35(1):58-66. doi: 10.1111/den.14409. Epub 2022 Aug 23.
- Individual participant dataSharing planned: Yes. The baseline demographics, the body weight changes，blood and fecal tests at each visit and the adverse effects will be available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Gastric Bypass Stent System in people with Obesity, run by Beijing Friendship Hospital at 1 site in China.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 18 May 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline excess weight loss at 4 weeks (time frame: 4 weeks). The study lists 7 primary outcomes in all. 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 NCT05864911, which also lists 3 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 18 May 2023.