ObesityNCT02231970
Endoscopic Sleeve Gastroplasty for Treatment of Obesity
A study testing Endoscopic sleeve gastroplasty in people with Obesity, run by Grupo Hospital de Madrid at 1 site in Spain.
Trial summary
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Endoscopic sleeve gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -
Who cannot join
- Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Sanchinarro
Madrid, Madrid, 28050
GONTRAND LOPEZ-NAVA, MD
About this study
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.
The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity
Read the detailed description
The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects
- Conditions
- Obesity
- Being tested
- Endoscopic sleeve gastroplasty
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplastyProcedure or surgery
Also called ESG
To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty | Experimental | The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus. Receives: Procedure: Endoscopic sleeve gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: One year
Secondary outcomes (1)
Safety
Any complications following the intervention like abdominal pain or bleeding
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Hospital de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid
- Investigators
- GONTRAND LOPEZ-NAVA, MD, Principal investigator, HOSPITAL UNIVERSITARIO SANCHINARRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231970
- Sponsor's protocol ID
- 657-GHM
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty for Treatment of Obesity
- ClinicalTrials.gov ID
- NCT02231970
- Acronym / sponsor ID
- 657-GHM
- Conditions
- Obesity
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Grupo Hospital de MadridUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- 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.
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.
The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity
Detailed description
The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty | Experimental | Procedure: Endoscopic sleeve gastroplastyThe intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -
Key exclusion criteria (2 listed)
- Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders
- -
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 sleeve gastroplastyAlso: ESGTo perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty | Procedure or surgery | Endoscopic sleeve gastroplasty |
Primary outcome
Change in body weight
Time frame: One year
1 secondary outcome
Safety
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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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.
GONTRAND LOPEZ-NAVA, MD principal investigator
HOSPITAL UNIVERSITARIO SANCHINARRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sleeve gastroplasty in people with Obesity, run by Grupo Hospital de Madrid at 1 site in Spain.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Sep 2014. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GONTRAND LOPEZ-NAVA, MD (+34917567800, gontrandlopeznava@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: One year). 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 5 Sep 2014.