UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059145 |
|---|---|
| Receipt number | R000067656 |
| Scientific Title | Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity |
| Date of disclosure of the study information | 2025/09/20 |
| Last modified on | 2025/09/20 05:37:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity
Acronym
Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity
Scientific Title
Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity
Scientific Title:Acronym
Clinical Trial Evaluating the Efficacy and Safety of Partial Gastric Plication in Patients with Obesity
Region
| Japan |
Condition
Condition
Clinical obesity
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Partial gastric plication (PGP) is a novel, minimally invasive bariatric procedure in which the lateral (greater curvature) portion of the stomach is folded inward (plication) laparoscopically, thereby reducing gastric volume to induce weight loss and improve obesity-related comorbidities. The aim of this clinical trial is to evaluate the safety and efficacy of PGP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Adverse events related to this treatment
-Adverse events/reactions will be assessed using the JCOG Postoperative Complications Criteria (Clavien-Dindo Classification), ver. 2.0.
Efficacy: Weight loss (percentage of total body weight loss, %TWL)
Key secondary outcomes
1, Body weight, BMI, waist circumference, and body composition
2, Glycemic, lipid, and blood pressure profiles
3, Clinical effects on obesity-related comorbidities
4, Changes in medication (dosage, type, and cost)
5, Quality of life assessment (SF-36, GIQOL)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Partial gastric plication (PGP) is a novel minimally invasive treatment for obesity that reduces gastric volume by laparoscopically folding the outer (greater curvature) side of the stomach inward (plication), with the aim of achieving weight loss and improving obesity-related health disorders.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Age between 18 and 65 years
2, Body mass index (BMI) equal to or greater than 25 kg/m2 at the time of enrollment
3, Presence of at least one obesity-related comorbidity (as defined in the 2022 Clinical Practice Guidelines for Obesity)
4, Ability to comply with the study protocol and attend follow-up visits
5, Provision of written informed consent
Key exclusion criteria
1. History of cardiovascular events within the past 6 months
2, History of congestive heart failure, angina pectoris, or peripheral vascular disease
3, Considered unsafe for surgery based on cardiac stress testing or 12-lead electrocardiogram
4, History of pulmonary embolism or thrombophlebitis within the past 6 months
5, Active malignancy
6, Severe anemia or coagulation disorders
7, Serum creatinine equal to or greater than 1.5 mg/dL
8, History of gastric surgery (cases with extremely low risk of recurrence, such as post-endoscopic resection for early gastric cancer, may be considered individually)
9, History of gastric or duodenal ulcer within the past 6 months
10, History of intra-abdominal infection (e.g., abscess, sepsis)
11, History of organ transplantation
12, HIV positivity, active tuberculosis, malaria, hepatitis B or C, liver cirrhosis, or inflammatory bowel disease
13, Pregnancy, breastfeeding, or planning to become pregnant within the next 2 years
14, Alcohol or drug dependence within the past 5 years
15, Active psychosocial or psychiatric disorders
16, Concurrent participation in another research protocol
17, Chronic or debilitating disease likely to interfere with protocol compliance
18, Any other condition judged by the investigator to render the subject ineligible
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Seki |
Organization
Yotsuya Medical Cube
Division name
Weight Loss and Metabolic Surgery Center
Zip code
102-0084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
y-seki@mcube.jp
Public contact
Name of contact person
| 1st name | Renzo |
| Middle name | |
| Last name | Yokoyama |
Organization
Yotsuya Medical Cube
Division name
Weight Loss and Metabolic Surgery Center
Zip code
102-0084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
Homepage URL
r-yokoyama@mcube.jp
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
Yotsuya Medical Cube
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yotsuya Medical Cube
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
Tel
03-3261-0401
r-yokoyama@mcube.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団あんしん会 四谷メディカルキューブ
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067656
