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Surgery Techniques for Obesity (CLIMB II Trial)

N/A
Recruiting
Led By Salvador Navarrete, MD
Research Sponsored by Salvador Navarrete
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,12,24 and 60 months from surgery
Awards & highlights
No Placebo-Only Group

Summary

"This trial will compare two different techniques for weight loss surgery. One technique uses fixed lengths for certain parts of the surgery, while the other adjusts the lengths based on the patient's small bowel length. The

Who is the study for?
This trial is for individuals with obesity, specifically those who are candidates for Roux-en-Y Gastric Bypass (RYGB) surgery. Participants should be willing to undergo a surgical procedure where the lengths of certain parts of their small bowel will be adjusted based on their total small bowel length.
What is being tested?
The study is testing if adjusting the limb lengths in RYGB surgery to match individual patient's anatomy leads to better weight loss and health outcomes compared to using standard fixed limb lengths. Patients will be randomly assigned to receive either the adjusted or standard surgery.
What are the potential side effects?
Potential side effects from RYGB surgery can include nutritional deficiencies, digestive issues such as nausea and vomiting, abdominal pain, and complications related to the surgical procedure itself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6,12,24 and 60 months from surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6,12,24 and 60 months from surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients
Secondary study objectives
To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis
To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity

Side effects data

From 2023 Phase 3 trial • 521 Patients • NCT04109066
65%
Alopecia
48%
Nausea
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Asthenia
20%
Vomiting
19%
Neutropenia
19%
Headache
19%
Neuropathy peripheral
17%
Constipation
16%
Neutrophil count decreased
16%
COVID-19
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
White blood cell count decreased
12%
Hyperglycaemia
12%
Radiation skin injury
11%
Myalgia
11%
Lymphopenia
9%
Epistaxis
9%
Urinary tract infection
9%
Infusion related reaction
9%
Hypertension
9%
Cough
9%
Pyrexia
9%
Pruritus
8%
Blood alkaline phosphatase increased
7%
Dysgeusia
7%
Dizziness
7%
Dyspepsia
7%
Hot flush
6%
Paraesthesia
6%
Hypersensitivity
6%
Peripheral sensory neuropathy
6%
Abdominal pain upper
6%
Mucosal inflammation
6%
Illness
6%
Back pain
6%
Insomnia
6%
Hyperthyroidism
6%
Pain in extremity
6%
Leukopenia
5%
Blood lactate dehydrogenase increased
5%
Anxiety
5%
Weight decreased
5%
Folliculitis
4%
Oedema peripheral
4%
Blood thyroid stimulating hormone increased
4%
Pain
4%
Dry mouth
4%
Adrenal insufficiency
4%
Abdominal pain
3%
Hyponatraemia
3%
Dyspnoea
3%
Nasopharyngitis
3%
Hypokalaemia
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Blood thyroid stimulating hormone decreased
3%
Stomatitis
3%
Lymphocyte count decreased
2%
Palpitations
2%
Depression
2%
Onycholysis
2%
Pulmonary embolism
2%
Breast pain
2%
COVID-19 pneumonia
2%
Dry skin
2%
Procedural pain
2%
Tachycardia
2%
Oropharyngeal pain
2%
Febrile neutropenia
2%
Bone pain
2%
Postoperative wound infection
2%
Thrombocytopenia
2%
Malignant neoplasm progression
2%
Rash maculo-papular
2%
Nail disorder
1%
Vertigo
1%
Cardio-respiratory arrest
1%
Thyroiditis subacute
1%
Arterial thrombosis
1%
Embolism
1%
Interstitial lung disease
1%
Myelosuppression
1%
Diabetic ketoacidosis
1%
Cardiac failure
1%
Immune-mediated adrenal insufficiency
1%
Myocardial infarction
1%
Chills
1%
Glomerulonephritis
1%
Upper respiratory tract infection
1%
Infection
1%
Cardiac perfusion defect
1%
Hypotension
1%
Hepatitis cholestatic
1%
Myocarditis
1%
Pneumonia bacterial
1%
Left ventricular failure
1%
Cervix carcinoma
1%
Anaphylactic reaction
1%
Colitis
1%
Pneumonia
1%
Intracranial pressure increased
1%
Pemphigoid
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: aRYGBExperimental Treatment1 Intervention
BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.
Group II: sRYGBActive Control1 Intervention
Standard fixed-length RYGB
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2490

Find a Location

Who is running the clinical trial?

Salvador NavarreteLead Sponsor
Salvador Navarrete, MDPrincipal InvestigatorThe Cleveland Clinic
~155 spots leftby Dec 2025
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