NCT02812160

Brief Summary

The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

May 25, 2016

Results QC Date

April 4, 2021

Last Update Submit

May 5, 2021

Conditions

Obesity

Keywords

weight loss

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Total Body Weight (%TBL) .

    The mean %TBL in the Spatz3 group should exceed the %TBL control group by 4.5%.

    32 weeks

Study Arms (2)

Spatz3 Adjustable Balloon

ACTIVE COMPARATOR

Spatz3 Adjustable Balloon with Dietary and exercise counselling

Device: Spatz3 Adjustable Balloon

Control

NO INTERVENTION

Dietary and Exercise counselling

Interventions

Spatz3 Adjustable BalloonDEVICE

An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed

Spatz3 Adjustable Balloon

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 22 - 65
  • BMI ≥ 30 and \<40
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
  • History of obesity (BMI ≥ 30) for at least 2 years
  • History of failure with non-surgical weight loss methods
  • Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling
  • Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
  • Ability to give informed consent
  • Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. The method of birth control must be documented and verified at follow-up. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician.

You may not qualify if:

  • 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, stomach or any type of hiatal hernia surgery.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
  • 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 atresias or stenoses.
  • A gastric mass.
  • A hiatal hernia \> 2cm or severe or intractable gastro-esophageal reflux symptoms.
  • Acid reflux symptoms to any degree that require more than one medication for symptom control.
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  • Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
  • Severe coagulopathy.
  • Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  • Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
  • Chronic abdominal pain
  • Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Surgical Specialists of Louisiana

Metairie, Louisiana, 70001, United States

Location

Endoscopic MicroSurgery Associates

Towson, Maryland, 21204, United States

Location

Brigham and Womans Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NY Manhattan VA Hospital

New York, New York, 10010, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Abu Dayyeh BK, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H, Chapman CG, Popov V, Jirapinyo P, Acosta A, Vargas EJ, Storm AC, Bazerbachi F, Ryou M, French M, Noria S, Molina D, Thompson CC. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet. 2021 Nov 27;398(10315):1965-1973. doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.

    PMID: 34793746DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Limitations and Caveats

There are no overall Limitations and Caveats

Results Point of Contact

Title
Jeffrey Brooks MD
Organization
Spatz FGIA Inc.
jeff@spatzmedical.net
1-516-303-0613

Study Officials

  • Barham AbuDayyeh, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Christopher C Thompson, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 24, 2016

Study Start

September 12, 2016

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

May 28, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-05

Locations

US(7)