ObesityNCT05938231
Tangji Gastric Bypass Stent Study for Obesity
A study testing Gastric Bypass Stent System and Dietary Intervention in people with Obesity, run by Hangzhou Tangji Medical Technology Co., Ltd. at 7 sites in China.
Trial summary
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for 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?
- Gastric Bypass Stent System and Dietary Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 7 sitesChina
- Study dates
- 15 Mar 2021to 7 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
- Aged 18-60 years, both male and female;
- Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention;
- Patients with ASA I~II grade;
- The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF).
Who cannot join
- Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month;
- Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month;
- Patients diagnosed with type 1 diabetes;
- Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load;
- Patients with iron deficiency or iron deficiency anemia;
- Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month;
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- Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 μmol/L;
- Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction;
- Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess;
- Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis;
- Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms;
- Patients with thyroid dysfunction;
- Patients with hemorrhage or potential hemorrhage in the digestive tract;
- Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract;
- Patients with a history of bowel obstruction or related diseases in the past year;
- Patients with a history of systemic lupus erythematosus or scleroderma;
- Patients with severe infections that are not controlled, not suitable for a procedure;
- Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator);
- Pregnant women or women having the plan for pregnancy;
- Drug abusers or alcohol addicts or patients with uncontrollable mental illness;
- Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit;
- Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months.
- Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038
The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, Neimenggu
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210000
The First Hospital of China Medical University
Shenyang, Liaoning
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Tangdu Hospital,Fouth Military Medical University
Xi’an, Shanxi
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Weight Loss Treatment for Obesity
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the China.
- Conditions
- Obesity
- Being tested
- Gastric Bypass Stent System, Dietary Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Bypass Stent SystemDevice
Subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months.
Dietary InterventionBehavioural
The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | In the trial group, the patients are treated with Gastric Bypass Stent System implanted under the gastroscope as well as the dietary intervention; The trial is carried out for 9 months, of which in the trial group, the patients have 3-month treatment period and then have 6-month follow-up period after the Gastric Bypass Stent System is removed. Receives: Device: Gastric Bypass Stent System; Behavioral: Dietary Intervention |
| control group | Other | In the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period. Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
EWL% at 3 months after device implantation procedure.
EWL%=(Preoperative weight - Weight at follow-up)/(Preoperative weight - Body weight at BMI of 25 kg/m2)*100%.
Measured: 3 months after device implantation procedure
Secondary outcomes (6)
Evaluation of device use in the trial group
Gastroscopy will be performed During the procedure (Visit 2) and at device removal(Visit 5).The user assesses whether the Gastric Bypass Stent can be used successfully during the procedure.
Abdominal X-ray will be performed 1 month after the implantation procedure (Visit 4) and before Gastric Bypass Stent retrieval (Visit 5). An abdominal plain film will be used to assess the status of the Gastric Bypass Stent.The stent is completely located in the duodenal bulb the stent is unfolded, and the outline is clear.
Measured: Baseline visit V2 and 1, 3 months after the procedure
Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled
Measured: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled
Measured: 3, 6, and 9 months after the procedure
Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled
Measured: 1, 3, 4, 6, and 9 months after the procedure
Changes in blood glucose-related indicators of the patients from Baseline
Through observe the changes of (fasting insulin, fasting blood glucose, fasting C-peptide) from baseline to 1, 3, 4, 6, and 9 months to evaluate whether implanting the investigational device will bring any changes to patients' blood glucose.
Measured: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Difference in blood lipid change from baseline (TC, TG, HDL-C, LDL-C) at 3, 4, 6, and 9 months after the patients are enrolled
Measured: from baseline to 3, 4, 6, and 9 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Mar 2021
- Primary completion3 May 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Tangji Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shutian Zhang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938231
- Sponsor's protocol ID
- HZTG01
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Weight Loss Treatment for Obesity
- ClinicalTrials.gov ID
- NCT05938231
- Acronym / sponsor ID
- HZTG01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hangzhou Tangji Medical Technology Co., Ltd.University, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 10 Jul 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.
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Device: Gastric Bypass Stent System, Behavioral: Dietary InterventionIn the trial group, the patients are treated with Gastric Bypass Stent System implanted under the gastroscope as well as the dietary intervention; The trial is carried out for 9 months, of which in the trial group, the patients have 3-month treatment period and then have 6-month follow-up period after the Gastric Bypass Stent System is removed. |
| control group | Other | Behavioral: Dietary InterventionIn the control group, the patients are treated only with dietary intervention; the patients have 9-month dietary intervention in the corresponding period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years, both male and female;
- Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention;
- Patients with ASA I~II grade;
- The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF).
Key exclusion criteria (23 listed)
- Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month;
- Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month;
- Patients diagnosed with type 1 diabetes;
- Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load;
- Patients with 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 |
|---|---|---|
| Gastric Bypass Stent SystemSubjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months. | Device | trial group |
| Dietary InterventionThe patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period. | Behavioural | control group, trial group |
Primary outcome
EWL% at 3 months after device implantation procedure.
Time frame: 3 months after device implantation procedure
EWL%=(Preoperative weight - Weight at follow-up)/(Preoperative weight - Body weight at BMI of 25 kg/m2)*100%.
6 secondary outcomes
Evaluation of device use in the trial group
Time frame: Baseline visit V2 and 1, 3 months after the procedure
Difference in BMI change from baseline between the two groups at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time frame: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Changes in HbA1c at 3, 6 and 9 months after the patients are enrolled
Time frame: 3, 6, and 9 months after the procedure
Drug dose of hypoglycemic agents at 1, 3, 4, 6 and 9 months after the patients are enrolled
Time frame: 1, 3, 4, 6, and 9 months after the procedure
Changes in blood glucose-related indicators of the patients from Baseline
Time frame: from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Difference in blood lipid change from baseline (TC, TG, HDL-C, LDL-C) at 3, 4, 6, and 9 months after the patients are enrolled
Time frame: from baseline to 3, 4, 6, and 9 months after the procedure.
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 10 Jul 2023.
- 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.
Shutian Zhang principal investigator
Beijing Friendship Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Bypass Stent System and Dietary Intervention in people with Obesity, run by Hangzhou Tangji Medical Technology Co., Ltd. at 7 sites 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 4 inclusion and 23 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 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
EWL% at 3 months after device implantation procedure. (time frame: 3 months after device implantation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2023.