ObesityNCT03088332
Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.
A study testing Endoscopic gastroplasty in people with Obesity, run by Kaiser Clinic and Hospital at 3 sites in Brazil.
Trial summary
Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endoscopic gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesBrazil
- Study dates
- 1 Jun 2017to 31 Dec 2020
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30 and < 36 with or without comorbidities
- BMI > 36 and < 40 without comorbidities
Who cannot join
- Prior gastric surgery
- Use of anticoagulants
- Psychiatric disorders
- Severe esophagitis
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Mario Covas Hospital
Santo André, São Paulo, 09190-615
Kaiser Day hospital
São José do Rio Preto, São Paulo
9 de Julho Hospital
São Paulo, São Paulo, 01409-002
About this study
Official title: Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.
Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Read the detailed description
The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the results of this procedure.
Patients and Methods: Patients with class I obesity with or without comorbidities and patients with class II obesity without comorbidities, irrespective of gender and ethnic background, from the state of São Paulo and other states of the country will be submitted to vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Information will be obtained during the outpatient follow-up at the Hospital Mario Covas including demographic (gender, age), clinical (height, weight, time after procedure, systemic arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative data (complications).
Preparation for the procedure: All the exams will be performed at the Hospital Mario Covas after the patients have fasted for at least 8 hours. The procedure will begin with the patient in left lateral decubitus under general anesthesia performed by an anesthesiologist. Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach is formed similar to a vertical gastrectomy.
Recovery after the procedure: After the procedure and recovery from anesthesia, all patients will be discharged but only together with a companion. All patients will receive guidance and will remain in touch with a physician to report any adverse signs or symptoms.
Outcomes Primary outcome: To confirm the efficacy of endoscopic sutures in the primary treatment of obesity.
Secondary outcome: To evaluate the use of the endoscopic sutures in relation to demographic data.
- Conditions
- Obesity
- Being tested
- Endoscopic gastroplasty
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gastroplastyProcedure or surgery
Vertical endoscopic gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic gastroplasty | Experimental | Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. Receives: Procedure: Endoscopic gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared
Measured: 48 weeks
Secondary outcomes (5)
Blood count
Measured in cmm
Measured: 48 weeks
Hb1AC
Measured in percentage
Measured: 48 weeks
Cholesterol
Measured in mg/dL
Measured: 48 weeks
Fasting blood glucose
Measured in mg/dL
Measured: 48 weeks
Procedural complications
Complications related to the procedure, either at the time of the procedure (bleeding, perforation and suture rupture) or in the postoperative period, performing an endoscopy at 6 months and 1 year to evaluate the suture line.
Measured: At the time of procedure and at 6 months and 1 year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luiz Guatavo de Quadros, MD, Principal investigator, Kaiser Clinica and Day Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088332
- Sponsor's protocol ID
- 1854540
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.
- ClinicalTrials.gov ID
- NCT03088332
- Acronym / sponsor ID
- 1854540
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaiser Clinic and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Mar 2017 (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.
Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Detailed description
The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the results of this procedure.
Patients and Methods: Patients with class I obesity with or without comorbidities and patients with class II obesity without comorbidities, irrespective of gender and ethnic background, from the state of São Paulo and other states of the country will be submitted to vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.
Information will be obtained during the outpatient follow-up at the Hospital Mario Covas including demographic (gender, age), clinical (height, weight, time after procedure, systemic arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative data (complications).
Preparation for the procedure: All the exams will be performed at the Hospital Mario Covas after the patients have fasted for at least 8 hours. The procedure will begin with the patient in left lateral decubitus under general anesthesia performed by an anesthesiologist. Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach is formed similar to a vertical gastrectomy.
Recovery after the procedure: After the procedure and recovery from anesthesia, all patients will be discharged but only together with a companion. All patients will receive guidance and will remain in touch with a physician to report any adverse signs or symptoms.
Outcomes Primary outcome: To confirm the efficacy of endoscopic sutures in the primary treatment of obesity.
Secondary outcome: To evaluate the use of the endoscopic sutures in relation to demographic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic gastroplasty | Experimental | Procedure: Endoscopic gastroplastyMake a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 30 and < 36 with or without comorbidities
- BMI > 36 and < 40 without comorbidities
Key exclusion criteria (4 listed)
- Prior gastric surgery
- Use of anticoagulants
- Psychiatric disorders
- Severe esophagitis
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 |
|---|---|---|
| Endoscopic gastroplastyVertical endoscopic gastroplasty | Procedure or surgery | Endoscopic gastroplasty |
Primary outcome
Weight loss
Time frame: 48 weeks
Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared
5 secondary outcomes
Blood count
Time frame: 48 weeks
Hb1AC
Time frame: 48 weeks
Cholesterol
Time frame: 48 weeks
Fasting blood glucose
Time frame: 48 weeks
Procedural complications
Time frame: At the time of procedure and at 6 months and 1 year follow-up period
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 17 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Luiz Guatavo de Quadros, MD principal investigator
Kaiser Clinica and Day Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic gastroplasty in people with Obesity, run by Kaiser Clinic and Hospital at 3 sites in Brazil.
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 2 inclusion and 4 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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?
Weight loss (time frame: 48 weeks). 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 17 Aug 2022.