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NCT Number: NCT02165059

GI Neuromuscular Pathology Prospective Registry

In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).

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Key information

Age range

6 month–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Attila Nakeeb, MD

SUB_INVESTIGATOR

Chandrashekhar A Kubal, MD

SUB_INVESTIGATOR

Jennifer Choi, MD

SUB_INVESTIGATOR

John M Wo, MD

PRINCIPAL_INVESTIGATOR

John Wo

CONTACT

[email protected]

Maureen Schilling

CONTACT

[email protected]

3172782064

Muhammad T Idress

SUB_INVESTIGATOR

Paul Herring, PhD

SUB_INVESTIGATOR

Tom V Nowak, MD

SUB_INVESTIGATOR

About this study

Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Study Group:

Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder.

Inclusion criteria

Control Group:

Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery

Patients who are organ donors and undergoing surgery

Exclusion criteria

Study Group:

Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease.

Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners

Exclusion criteria

Control Group:

Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor

Treatment and study plan

Surgical Full Thickness Biopsy

Procedure

Eligible subjects will undergo a surgical full thickness biopsy of the stomach and/or proximal jejunum as part of their planned surgery.

Other names: Biopsy, Surgical, Full-thickness, Stomach

Primary outcomes

  1. Biologic Markers As Predictors for Gastric Electrical Stimulation Outcomes

    Time frame: from implantation to 6 months after

    To determine if ICC abnormalities of the stomach and proximal jejunum can be used as a biologic marker in predicting clinical outcome in patients undergoing surgical implantation of gastric electrical stimulation (GES) for severe gastroparesis.

Study contacts

Contact information is provided by the study sponsor or research team.

John Wo

CONTACT

[email protected]

Maureen M Schilling, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Indiana University GI Neuromuscular Pathology Prospective Registry

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2014
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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