ObesityPRETTiNCT05677464
Prospective Multicenter Study With the Endomina® Triangulation Platform
An observational study of Obesity, run by Endo Tools Therapeutics S.A. at 1 site in Belgium.
Trial summary
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2020to 31 Mar 2026
- How long will I take part?
- 36 Months
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients, who require endoscopic gastroplasty (ESG) and who are selected by multidisciplinary team/investigators to be treated with the endomina® device.
Who may be able to join
- Patient must be willing to provide written informed consent
- Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
- Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)
Who cannot join
- Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
- Any malformation from mouth to esophagus (including pharynx)
- Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
- Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
- Impending surgery 60 days post intervention of the treated section of the GI tract
- Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Endo Tools Therapeutics S.A.
Gosselies, Wallonia, 6041
Mrs Leclercq, 003271495517, pretti@endotools.be
003271919409, info@endotools.be
About this study
Official title: Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice
Read the detailed description
This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.
- Conditions
- Obesity
- Keywords
- Obesity, Gastroplasty, Endoscopic gastroplasty, endomina
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
Occurrence of Serious Adverse Device Effects at 12 months.
Measured: 12 months
Technical success
Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start8 Jun 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2026 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Endo Tools Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mrs Leclercq, Study director, Endo Tools Therapeutics S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677464
- Sponsor's protocol ID
- ST-2019-001
- Acronym
- PRETTi
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty
- ClinicalTrials.gov ID
- NCT05677464
- Acronym / sponsor ID
- PRETTi / ST-2019-001
- Conditions
- Obesity
- Keywords
- Obesity, Gastroplasty, Endoscopic gastroplasty, endomina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Endo Tools Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Jan 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.
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice
Detailed description
This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, who require endoscopic gastroplasty (ESG) and who are selected by multidisciplinary team/investigators to be treated with the endomina® device.
Key inclusion criteria (3 listed)
- Patient must be willing to provide written informed consent
- Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
- Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)
Key exclusion criteria (6 listed)
- Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
- Any malformation from mouth to esophagus (including pharynx)
- Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
- Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
- Impending surgery 60 days post intervention of the treated section of the GI tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety outcome
Time frame: 12 months
Occurrence of Serious Adverse Device Effects at 12 months.
Technical success
Time frame: 1 day
Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mrs Leclercq study director
Endo Tools Therapeutics S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Endo Tools Therapeutics S.A. at 1 site in Belgium.
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 3 inclusion and 6 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 10 Jan 2023. 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 Belgium. 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 Mrs Leclercq (003271495517, pretti@endotools.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: 12 months). 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 10 Jan 2023.