Weight LossNCT07276815
OverStitch NXT Endoscopic Suture System
A study testing OverStitch NXT Endoscopic Suture System in people with Weight Loss, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- OverStitch NXT Endoscopic Suture System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, or subjects who have reached the legal age for signing informed consent in accordance with local laws and regulations.
- BMI ≥ 32.5 kg/m²; or BMI ≥ 27.5 kg/m² combined with type 2 diabetes mellitus (regardless of the effectiveness of medical treatment for type 2 diabetes); or BMI between 27.5 kg/m² and 32.5 kg/m² with ineffective medical weight loss or combined with other obesity-related diseases for which medical treatment is ineffective.
- Willing to comply with the long-term strict dietary restrictions required by the surgery.
- Capable of providing informed consent, able to complete all routine follow-up visits, and willing to abide by the protocol requirements, including signing the informed consent form, completing relevant examinations, and receiving dietary counseling.
- Females of childbearing potential (i.e., premenopausal or not sterilized) must agree to use adequate contraceptive measures.
Who cannot join
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, specific inflammation such as Crohn's disease, and the doctor judges that it may affect the operation or efficacy of ESG.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenosis.
Show all 30Show fewer
- History of gastrointestinal stromal tumors, gastrointestinal cancer, low-grade or high-grade gastric intraepithelial neoplasia, or familial or non-familial adenomatous polyposis syndrome.
- Gastric masses or untreated gastric polyps with a diameter > 1 cm.
- Hiatal hernia (Z-line displacement above the diaphragm > 4 cm) or severe/refractory gastroesophageal reflux symptoms, which the physician judges may affect the performance or prognosis of ESG.
- Structural abnormalities of the esophagus or pharynx that may impede endoscopic passage (e.g., strictures or diverticula), which the physician judges may affect the performance or prognosis of ESG.
- Gastrointestinal motility disorders (e.g., achalasia, severe esophageal motility disorders, gastroparesis, or intractable constipation), which the physician judges may affect the performance or prognosis of ESG.
- Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.
- Coagulopathy with INR > 1.5 that cannot be corrected (per physician's judgment) or requirement for continuous full anticoagulant therapy, and/or any underlying diseases associated with high bleeding risk.
- Insulin-dependent diabetes mellitus (type 1 or type 2), or high likelihood of requiring insulin therapy within the next 12 months.
- Decompensated cirrhosis, or acute/chronic liver dysfunction that the physician judges make the subject unsuitable for ESG treatment.
- Diagnosis of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma) or immunocompromise, which the physician assesses may affect the performance or prognosis of ESG.
- Known history of endocrine diseases affecting body weight (e.g., Cushing's syndrome, uncontrolled hypothyroidism, or hyperthyroidism), which the physician assesses may affect the performance or prognosis of ESG.
- Anemia: Hemoglobin (Hgb) < 110 g/L for females; Hgb < 120 g/L for males.
- Any other medical conditions precluding elective endoscopy, such as poor general health, history of severe renal, hepatic, cardiac, and/or pulmonary diseases, and/or severe or uncontrolled psychiatric illnesses or abnormalities that may impair the patient's ability to understand or comply with follow-up visits and lifestyle interventions.
- Active psychological issues as determined by a psychologist or psychiatrist, precluding participation in lifestyle modification programs.
- Unwillingness to participate in the established medically supervised dietary and behavioral modification programs, as well as routine medical follow-up.
- Daily treatment with prescribed high-dose aspirin (> 80 mg per day), non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, corticosteroids, immunosuppressants, or other gastric irritant medications.
- Interval use of medications that may be affected by changes in gastric emptying (e.g., antiepileptic drugs or antiarrhythmic drugs).
- Inability or unwillingness to take prescribed proton pump inhibitor (PPI) medications.
- Current use of weight loss medications or other weight loss devices or use within the past 90 days.
- Current participation in a clinical trial involving investigational drugs or devices, or participation in such a trial within 30 days prior to enrollment in this study.
- Use of intragastric devices within 30 days prior to this study, which the physician assesses may affect the performance or prognosis of ESG.
- Unwillingness to avoid any reconstructive and/or plastic surgeries that may affect body weight during the study (e.g., mammoplasty, liposuction).
- Other conditions deemed unsuitable for endoscopy or ESG treatment by the investigator, including but not limited to conditions that the investigator believes may expose the subject to significant risks, confound study results, increase risks associated with endoscopy and/or endoscopic procedures, or substantially interfere with the subject's participation in the study.
- Pregnancy, lactation, or intention to become pregnant during the study (for females of childbearing potential).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shutian Zhang contact
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Affiliated to Capital Medical University
Beijing, China/Beijing, 100050
Shutian Zhang, Dr, 15810430945, zhangshutian@ccmu.edu.com
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About this study
Official title: Gathering of Results in Eligible Asian Obese Populations About Safety and Effectiveness of Overstitch ESG Trial
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
Read the detailed description
The study is a prospective, multicenter, randomized controlled trial
This study is planned to be conducted at 10 sites, with each center initially enrolling 2 roll-in cases (totaling 20 cases). After each site completes the enrollment of its roll-in cases, the remaining subjects will be randomly divided into two groups (the treatment group and the control group) via a central randomization system. Each group will ultimately enroll 58 subjects, resulting in a total sample size of 136 for the study.
Roll-in Cases: ESG combined with lifestyle management for 12 months. treatment group: ESG combined with lifestyle management for 12 months. control group: Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward.
- Conditions
- Weight Loss
- Being tested
- OverStitch NXT Endoscopic Suture System
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverStitch NXT Endoscopic Suture SystemDevice
The OverStitch NXT Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor sutures can be placed for endoscopic sleeve gastroplasty（ESG）.
| Study group | Role | What they receive |
|---|---|---|
| Roll-in Cases | Other | ESG combined with lifestyle management for 12 months Receives: Device: OverStitch NXT Endoscopic Suture System |
| Treatment group | Experimental | ESG combined with lifestyle management for 12 months. Receives: Device: OverStitch NXT Endoscopic Suture System |
| Control group | No intervention | Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
%TBWL (Defined as the percentage of total body weight loss)
%TBWL is defined as the percentage of total body weight loss
Measured: At 12 months after the intervention.
The response rate at the 12th month after the intervention
Response is defined as having a percentage of total body weight loss (%TBWL) of ≥ 5%
Measured: At 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start6 Aug 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shutian Zhang, Dr, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276815
- Sponsor's protocol ID
- E7241
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gathering of Results in Eligible Asian Obese Populations About Safety and Effectiveness of Overstitch ESG Trial
- ClinicalTrials.gov ID
- NCT07276815
- Acronym / sponsor ID
- E7241
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 11 Dec 2025 (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.
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
Detailed description
The study is a prospective, multicenter, randomized controlled trial
This study is planned to be conducted at 10 sites, with each center initially enrolling 2 roll-in cases (totaling 20 cases). After each site completes the enrollment of its roll-in cases, the remaining subjects will be randomly divided into two groups (the treatment group and the control group) via a central randomization system. Each group will ultimately enroll 58 subjects, resulting in a total sample size of 136 for the study.
Roll-in Cases: ESG combined with lifestyle management for 12 months. treatment group: ESG combined with lifestyle management for 12 months. control group: Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roll-in Cases | Other | Device: OverStitch NXT Endoscopic Suture SystemESG combined with lifestyle management for 12 months |
| Treatment group | Experimental | Device: OverStitch NXT Endoscopic Suture SystemESG combined with lifestyle management for 12 months. |
| Control group | No intervention | –Lifestyle management alone for 12 months, followed by evaluation. Eligible participants may undergo ESG afterward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older, or subjects who have reached the legal age for signing informed consent in accordance with local laws and regulations.
- BMI ≥ 32.5 kg/m²; or BMI ≥ 27.5 kg/m² combined with type 2 diabetes mellitus (regardless of the effectiveness of medical treatment for type 2 diabetes); or BMI between 27.5 kg/m² and 32.5 kg/m² with ineffective medical weight loss or combined with other obesity-related diseases for which medical treatment is ineffective.
- Willing to comply with the long-term strict dietary restrictions required by the surgery.
- Capable of providing informed consent, able to complete all routine follow-up visits, and willing to abide by the protocol requirements, including signing the informed consent form, completing relevant examinations, and receiving dietary counseling.
- Females of childbearing potential (i.e., premenopausal or not sterilized) must agree to use adequate contraceptive measures.
Key exclusion criteria (30 listed)
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, specific inflammation such as Crohn's disease, and the doctor judges that it may affect the operation or efficacy of ESG.
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 |
|---|---|---|
| OverStitch NXT Endoscopic Suture SystemThe OverStitch NXT Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor sutures can be placed for endoscopic sleeve gastroplasty（ESG）. | Device | Roll-in Cases, Treatment group |
Primary outcome
%TBWL (Defined as the percentage of total body weight loss)
Time frame: At 12 months after the intervention.
%TBWL is defined as the percentage of total body weight loss
The response rate at the 12th month after the intervention
Time frame: At 12 months after the intervention
Response is defined as having a percentage of total body weight loss (%TBWL) of ≥ 5%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Shutian Zhang contact
Shutian Zhang, Dr principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OverStitch NXT Endoscopic Suture System in people with Weight Loss, run by Boston Scientific Corporation 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 5 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shutian Zhang, Dr (13911021992, zhangshutian@ccmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%TBWL (Defined as the percentage of total body weight loss) (time frame: At 12 months after the intervention.). The study lists 2 primary outcomes in all. 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 27 Oct 2026.