ReShape Intragastric Balloon for the Treatment of Obesity (ITALYIII)

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ClinicalTrials.gov Identifier: NCT01024465

Recruitment Status : Completed

First Posted : December 2, 2009

Results First Posted : September 11, 2015

Last Update Posted : September 29, 2015

Sponsor:

Collaborators:

Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY

Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY

Information provided by (Responsible Party):

ReShape Lifesciences

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Obesity
Intervention	Device: ReShape Duo Balloon
Enrollment	26

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	ReShape Duo Balloon
Arm/Group Description	Patients seeking weight loss with a...
Arm/Group Description	Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon
Period Title: Overall Study
Started	26
Completed	23
Not Completed	3
Reason Not Completed
Adverse Event	2
Physician Decision	1

Baseline Characteristics

Arm/Group Title		ReShape Duo Balloon
Arm/Group Description		Patients seeking weight loss with a...
Arm/Group Description		Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon
Overall Number of Baseline Participants		26
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Participants were enrolled who met the study's inclusion/exclusion criteria.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	26 participants
		39.7 (11.2)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	26 participants
	Female	22 84.6%
	Male	4 15.4%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	26 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	26 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Total Weight Loss
Description	Mean weight loss in kilograms compared with the baseline value through...
Description	Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Time Frame	baseline to 180 days

Outcome Measure Data

Analysis Population Description

Subjects with a weight recorded at 6 months


Arm/Group Title	ReShape Duo Balloon
Arm/Group Description:	Patients seeking weight loss with a...
Arm/Group Description:	Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon
Overall Number of Participants Analyzed	22
Mean (Standard Deviation) Unit of Measure: kg
	-9.4 (6.3)

Adverse Events

Time Frame	180 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	ReShape Duo Balloon
Arm/Group Description	Patients seeking weight loss with a...
Arm/Group Description	Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon
All-Cause Mortality
	ReShape Duo Balloon
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	ReShape Duo Balloon
	Affected / at Risk (%)
Total	0/26 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ReShape Duo Balloon
	Affected / at Risk (%)
Total	16/26 (61.54%)
Gastrointestinal disorders
nausea/vomiting after discharge ^† 1	4/26 (15.38%)
gastric bloating ^† 1	4/26 (15.38%)
epigastric pain ^† 1	3/26 (11.54%)
GERD ^† 1	3/26 (11.54%)
ulcer at removal ^† 1	3/26 (11.54%)
diarrhea ^† 1	2/26 (7.69%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, verbatim

Limitations and Caveats

No limitations nor caveats apply.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

Upon study conclusion, the PI has the right to use the study data for educational purposes, scientific conferences and publications. The sponsor will have a period of 15 days (for abstracts) and 30 days (for scientific publications) to review the proposal for disclosure / publication for the sole purpose of protecting any confidential information. If such disclosure contains Confidential Information, the PI agrees to remove such Confidential Information.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Director of Clinical Operations
Organization:	ReShape Medical
Phone:	949-429-6680
EMail:	lfong@reshapemedical.com

Layout table for additonal information

Responsible Party:	ReShape Lifesciences
ClinicalTrials.gov Identifier:	NCT01024465
Other Study ID Numbers:	2009-1
First Submitted:	November 25, 2009
First Posted:	December 2, 2009
Results First Submitted:	August 13, 2015
Results First Posted:	September 11, 2015
Last Update Posted:	September 29, 2015

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