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ObesityNCT03472196

NitiNotes' EndoZip System for the Treatment of Obesity

A study testing EndoZip System in people with Obesity, run by Nitinotes Surgical Ltd. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity
What is being tested?
EndoZip System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSpain
Study dates
21 Mar 2018to 8 May 2019
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject, male or female, is age 18 to 60 years of age.
  • Subject must be able to understand and be willing to sign an informed consent form.
  • Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
  • Subject has a BMI of 30-40 kg/m2
  • Have had no significant weight change (±5% of total body weight) during 6 months prior to enrollment
  • Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
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  • Subject must be of sufficient and stable medical and mental health, as evaluated by the Principal Investigator.
  • Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
  • Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
  • Subject agrees not to have any additional weight loss interventional procedures, such as mammoplasty or abdominal lipoplasty or liposuction, or take any over the counter or prescription weight loss medication for the entire study participation duration
  • Type II Diabetes patients who are treated with oral glucose lowering agent and are stable are acceptable.

Who cannot join

  • Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
  • Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
  • Uncontrolled diabetes or change in diabetes medication and/or dosage in the 3 months prior to enrolment
  • Uncontrolled hypertension
  • Subject with heart failure, NYHA grade 2 and above.
  • Subject has pre-existing respiratory disease, such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
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  • Subject has significant esophageal disease including Zenker's diverticulum, severe gastro-esophageal reflux disease (GERD), stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility, which is not controlled with medication.
  • Subject has renal and/or hepatic insufficiency/disease (creatinine above 1.5 mg/dL)
  • Subject has thyroid disease, which is not controlled with medication.
  • Subject is diagnosed with ostocorticular pain, pre-neoplastic lesions or coagulation conditions that may prevent him/her from undergoing a surgical procedure.
  • Subject has a history of intestinal strictures or adhesions and/or any condition that could preclude passage of endoluminal instruments.
  • Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device use), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
  • Subject is diagnosed with a coagulation disorder.
  • Subjects undergoing chronic steroid therapy.
  • Subjects undergoing immunosuppressive therapy.
  • Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
  • Subjects who have known hiatal hernias greater than 5 cm.
  • Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
  • Subject has active Crohn's disease or Colitis.
  • Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  • Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 6 months prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study and their participation may interfere with the current study.
  • Subject has any condition that, at the discretion of the investigator, would preclude participation in the study.
  • Unstable diabetes patients who are treated with insulin.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

Other trials in Spain

About this study

Official title: First in Human Clinical Study to Assess the Safety and Preliminary Performance of NitiNotes' Endoluminal Gastroplasty System (EndoZip) for the Treatment of Obesity

This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.

Conditions
Obesity
Being tested
EndoZip System
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoZip SystemDevice

    The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within.

    Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.

Study groups in NCT03472196
Study groupRoleWhat they receive
EndoZip SystemExperimentalThe Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Receives: Device: EndoZip System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary - Serious Adverse Events

    Incidence of device related SAEs within 6 months post procedure

    Measured: 6 months

Secondary outcomes (2)

  1. Efficacy - Suture Durability

    Success rate at 6 months after procedure by assessment of the stitches durability / gastroplasty shape in the stomach, to be determined by the investigator using endoscopy and/or Barium X-ray (per physician discretion) at pre-determined intervals.

    Measured: 6 months

  2. Efficacy - % Excess Weight Loss (EWL)

    %EWL after 6 months from baseline

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start21 Mar 2018
  3. Primary completion8 May 2019
  4. Study completion8 May 2019

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single arm, open label study
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03472196
Sponsor's protocol ID
CLP-01
Status last verified
Mar 2019
First submitted
4 Mar 2018
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lopez-Nava G, Asokkumar R, Rull A, Fernandez-Corbelle, Bautista I, Dayyeh BA. Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study. Obes Surg. 2020 May;30(5):1696-1703. doi: 10.1007/s11695-019-04370-w.

    PubMed 31898051

Questions about this trial

What is this clinical trial studying?

A study testing EndoZip System in people with Obesity, run by Nitinotes Surgical Ltd. 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 11 inclusion and 23 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 23 Feb 2021. 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?

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?

Primary - Serious Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03472196, which also lists 1 linked publication.

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 23 Feb 2021.

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