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Endoscopic Suturing for Primary Obesity Treatment (PROMISE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662024
First Posted: August 10, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Apollo Endosurgery, Inc.
Information provided by (Responsible Party):
Christopher Thompson, Brigham and Women's Hospital
Results First Submitted: December 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obesity
Body Weight
Overweight
Intervention: Device: Endoscopic gastric restrictive procedure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Endoscopic Gastric Restrictive Procedure

Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.

Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.


Participant Flow:   Overall Study
    Endoscopic Gastric Restrictive Procedure
STARTED   20 
COMPLETED   15 
NOT COMPLETED   5 
Pregnancy                2 
Withdrawal by Subject                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adults who are suffering from obesity with a Body Mass Index (BMI) of 30 - 35 kg/m^2 seeking a minimally invasive alternative to bariatric surgery.

Reporting Groups
  Description
Endoscopic Gastric Restrictive Procedure

Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.

Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures


Baseline Measures
   Endoscopic Gastric Restrictive Procedure 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Full Range)
 36.7 
 (34.4 to 39.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20 100.0% 
Male      0   0.0% 
Initial Weight (kg) 
[Units: Kg]
Mean (Full Range)
 90.4 
 (88.4 to 92.4) 
Initial BMI (kg/m^2) 
[Units: Kg/m^2]
Mean (Full Range)
 33.4 
 (33.1 to 33.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 12 months ]

2.  Primary:   Evaluation of Technical Feasibility of the Procedure   [ Time Frame: Day 0 - Procedure Day ]

3.  Secondary:   Percent Excess Weight Loss   [ Time Frame: 12 Months ]

4.  Secondary:   Durability   [ Time Frame: 12 months ]

5.  Secondary:   Percentage of Total Body Weight Loss   [ Time Frame: 12 Months ]

6.  Secondary:   BMI Loss (kg/m^2)   [ Time Frame: 12 Months ]

7.  Secondary:   Waist Circumference Loss (cm)   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Early termination and withdrawal of 5 subjects leads to small numbers of subjects analyzed.

No sham comparator.

Durability measures at 12 month endoscopy was difficult to quantify.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher C. Thompson, MD, MSc
Organization: Brigham and Women's Hospital
phone: 617-525-8266
e-mail: ccthompson@bwh.harvard.edu


Publications:

Responsible Party: Christopher Thompson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01662024     History of Changes
Other Study ID Numbers: 2012P-000799
First Submitted: June 15, 2012
First Posted: August 10, 2012
Results First Submitted: December 7, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017