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Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study

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Abstract

Introduction

Endoscopic gastroplasty and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study is to assess the feasibility and safety of a novel fully automated, operator-independent endoscopic suturing system (EndoZip™) for minimally invasive treatment of obesity.

Design

Single-center pilot feasibility study.

Patients

Eleven patients with a body mass index (BMI) of 30 to 40 kg/m2 with or without obesity-associated comorbidity.

Interventions

Gastric volume reduction with EndoZip™ system.

Main Outcome Measurements

Primary outcome was to assess the technical feasibility and safety. The secondary outcome was to determine %total body weight loss (TBWL) and %excess weight loss (EWL) at 6 months.

Results

The mean ± SD age was 42.7 ± 5.6 years, and the mean ± SD BMI was 36.9 ± 2.8 kg/m2. A majority (64%) were men. The procedure was technically successful (100%) in all patients. A median of 3 (range, 2–4) full-thickness sutures were placed, and the mean procedure time was 54.6 ± 23.9 (23–100) min. No immediate complications occurred, and all were discharged in 24 h. One patient developed respiratory infection 3 days after the procedure and required hospitalization. The infection was mild and resolved with antibiotic treatment. At 6-month follow-up, the mean ± SD TBWL, %TBWL, and %EWL were 17.8 ± 6.7 kg, 16.2 ± 6.0%, and 54.3 ± 28.4%, respectively (p < 0.001).

Limitations

Limited number of patients.

Conclusion

Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising. An extended feasibility study on a larger sample size is being planned (Clinicaltrials.gov. NCT03472196).

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Abbreviations

TBWL:

Total body weight loss

EWL:

Excess weight loss

BMI:

Body mass index

IGB:

Intragastric balloon

ESG:

Endoscopic sutured gastroplasty

SD:

Standard deviation

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Funding

The study was sponsored by Nitinotes Surgical Ltd.

Author information

Author notes

  1. Gontrand Lopez-Nava and Ravishankar Asokkumar contributed equally to this work.

Authors and Affiliations

  1. Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Calle de Oña 10, Madrid, Spain

    Gontrand Lopez-Nava, Ravishankar Asokkumar, Angel Rull,  Fernandez-Corbelle & Inmaculada Bautista

  2. Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore, Singapore

    Ravishankar Asokkumar

  3. Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA

    Barham Abu Dayyeh

Authors
  1. Gontrand Lopez-Nava
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  2. Ravishankar Asokkumar
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  3. Angel Rull
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  4. Fernandez-Corbelle
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  5. Inmaculada Bautista
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  6. Barham Abu Dayyeh
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Corresponding author

Correspondence to Gontrand Lopez-Nava.

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Conflict of Interest

Dr. Gontrand Lopez-Nava is a consultant for Nitinotes Surgical, Apollo Endosurgery, and USGI Medical. Dr. Barham Abu Dayyeh is a consultant for Boston Scientific, Metamodix, BFKW, USGI Medical and Nitinotes Surgical. All other authors have no disclosure.

Statement of Informed Consent

Informed consent was obtained from all individual participants included in the study.

Ethics Approval

The study was conducted following the good clinical practice guidelines and adhered to the recommendation of the declaration of Helsinki. The institutional review board approved the study.

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Lopez-Nava, G., Asokkumar, R., Rull, A. et al. Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study. OBES SURG 30, 1696–1703 (2020). https://doi.org/10.1007/s11695-019-04370-w

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