Tangji EU Gastric Bypass Stent Study for Obesity

March 13, 2023 updated by: Hangzhou Tangji Medical Technology Co., Ltd.

A Prospective, Open-label, Multicenter, Single-arm 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 European Union (EU) and United Kingdom (UK).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 pivotal, prospective, multicenter, single-arm 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 European Union (EU) and United Kingdom (UK). This clinical investigation will be used as an EU/UK bridging study and, with the ongoing clinical investigation in China (Protocol number: HZTG01), will be used to evaluate the safety and performance of the investigational device for the intended use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and female aged 18 to 60 years old.
  • Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System.
  • Patients with American Society of Anesthesiologists (ASA) I~II grade. Exception: patients with BMI ≥ 40 kg/m2 may be included upon the Investigator's discretion if they have no other severe systemic disease.
  • Able and willing to provide informed consent for participation in the clinical investigation and comply with all study procedures and assessments.

Exclusion Criteria:

  • Have lost more than 4.5 kg in the past three months or have taken weight loss drugs in the past month.
  • Patients with secondary obesity; a medical condition that has caused weight gain such as endocrine disorders and hypothalamic disorders.
  • Chronic, daily use of systemic anti-inflammatory or corticosteroid medications (e.g., ibuprofen, prednisolone) for more than 1 week (not including low-dose aspirin for cardiac prophylaxis or inhaled corticosteroids).
  • Patients with less than one-year continuous treatment before baseline with hypoglycemic drugs with known weight loss effects (e.g., GLP-1 agonists, SGLT-2 inhibitors, DDP-4 inhibitors).
  • 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 significant iron deficiency or iron deficiency anemia upon the Investigator's discretion.
  • Patients with coagulation dysfunction and chronic, daily use of systemic anti-inflammatory or anti-coagulation medication in the past month (not including low-dose aspirin).
  • Patients with severe liver and kidney dysfunction, and a serum creatinine concentration ≥ 180 μmol/L.
  • Patients with Class III heart function of New York Heart Association Functional Classification (NYHA) or higher upon the Investigators evaluation.
  • Patients with pulmonary dysfunction upon the Investigator's evaluation.
  • Patients who have undergone Endoscopic Retrograde Cholangiopancreatography (ERCP) or have a history of cholecystitis or liver abscess.
  • Patients with a duodenal ulcer, gastric ulcer, or previous and existing pancreatitis.
  • Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms.
  • Patients with on-going thyroid dysfunction, not stabilized despite appropriate treatment.
  • 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.
  • Patients with poor general condition and having endoscopic contraindications (as evaluated by the Investigator).
  • Pregnant women or planning to become pregnant.
  • Patients with an alcohol dependence or substance abuse.
  • Patients with unstable psychiatric disorders.
  • Patients who are enrolled in another investigational study and have not completed the required follow-up period.
  • Patients with an allergy to any of the components of the investigational device.
  • Presence of helicobacter pylori resistant to medical treatment.
  • Patients with any other conditions evaluated by the Investigators as unsuitable for participating in the clinical investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
A single arm study, only investigational product-the Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. to evaluate the safety and performance of the investigational device for the intended use.
Device: A prospective, open-label, multicenter, single-arm clinical study to evaluate the safety and performance of the Gastric Bypass Stent System as a weight loss treatment for obesity
This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 9 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance（EFFICACY） Endpoint:
Time Frame: 3 months after device implantation procedure
1) Extra weight loss percentage (EWL%) at 3 months after device implantation procedure.
3 months after device implantation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use abdominal X-ray evaluate Device implantation status
Time Frame: V1-V5(90±7 days)

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.

  1. The stent is completely located in the duodenal bulb.
  2. The stent is unfolded, and the outline is clear.
V1-V5(90±7 days)
Performance（EFFICACY） Endpoint:
Time Frame: 1, 3, 4, 6, and 9 months after the procedure.
BMI change from baseline at 1, 3, 4, 6, and 9 months after the procedure.
1, 3, 4, 6, and 9 months after the procedure.
Performance（EFFICACY） Endpoint:
Time Frame: 3, 6, and 9 months after the procedure.
Changes in glycated hemoglobin (HbA1c) at 3, 6, and 9 months after the procedure.
3, 6, and 9 months after the procedure.
Performance（EFFICACY） Endpoint:
Time Frame: at 1, 3, 4, 6, and 9 months after the procedure.
Drug dose of hypoglycemic agents at 1, 3, 4, 6, and 9 months after the procedure.
at 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.
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.
from baseline to 1, 3, 4, 6, and 9 months after the procedure.
Performance（EFFICACY） Endpoint:
Time Frame: from baseline to 3, 4, 6, and 9 months after the procedure.
Difference in blood lipid (total cholesterol [TC], triglyceride [TG], high density lipoprotein C [HDL-C], low-density lipoprotein C [LDL C]) change from baseline to 3, 4, 6, and 9 months after the procedure.
from baseline to 3, 4, 6, and 9 months after the procedure.
Satisfaction assessed by the quality of life questionnaire (BQL)
Time Frame: from baseline to 9 months after the procedure.
The bariatric quality of life (BQL) questionnaire will be used to measure subject quality of life. The BQL contains 13 items rated on a scale of 1 to 5 (Absolutely wrong to Absolutely right, respectively). The maximum total score is 65, with a higher score indicating a higher quality of life. BQL total scores will be recorded in the eCRF to evaluate patients' life quality before and after percudure.
from baseline to 9 months after the procedure.
Satisfaction assessed by the visual analog scale (VAS) scale
Time Frame: VAS scale will be assessed before and after procedure，from baseline to 1, 3, 4, 6, and 9 months after the procedure.
The visual analog scale (VAS) is a tool widely used to measure subject-reported pain intensity. It is a 10cm long ruler, with a "0" end and a "10" end, with 0 indicating no pain and 10 indicating the worst possible pain in subject's imagination.
VAS scale will be assessed before and after procedure，from baseline to 1, 3, 4, 6, and 9 months after the procedure.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence numbers of the Clinically significant changes of laboratory tests throughout the clinical investigation.
Time Frame: Through out the whole study V1-V8(9 months after the procedure)
Collect the numbers of the Clinically significant changes of laboratory tests based on investigator's evaluation to the lab tests result before and after procedure.
Through out the whole study V1-V8(9 months after the procedure)
Occurrence numbers of complications associated with the investigational device and the procedure.
Time Frame: Through out the whole study V1-V8(9 months after the procedure)
Collect the complications associated with the investigational device and the procedure based on investigator's clincial judgement.
Through out the whole study V1-V8(9 months after the procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Tangji Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BL-RD08-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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