INGEST I Pilot Study

NCT03885310 | Unknown

• 1 other identifier: PR2001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

Conditions

Esophageal Stricture

Outcome Measures

Primary Outcomes (1)

• Incident of serious balloon dilation-related complications

  Adverse events such as perforation, bleeding requiring intervention, severe pain during swallowing, infection requiring hospitalization or IV antibiotics, dysphagia requiring re-intervention at determined by the attending physician

  30 days

Secondary Outcomes (5)

• Numbers of additional esophageal dilation procedures

  30 days, 3 months, 6 months, and 12 months

• Time to first dysphagia symptom recurrence

  30 days, 3 months, 6 months, and 12 months

• Improvement in dysphagia score

  30 days, 3 months, 6 months, and 12 months

• Esophageal stricture diameter

  30 days, 3 months, 6 months, and 12 months

• Technical success

  Time of procedure

Study Arms (1)

DCB Treatment

EXPERIMENTAL

Stricture patients treated by DCB

Device: GIE Drug Coated Balloon

Interventions

GIE Drug Coated Balloon DEVICE

The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.

DCB Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80 years.
• Benign esophageal stricture with diameter less than 10 mm (barium esophagram).
• Dysphagia score of 2 to 4 (Ogilvie Dysphagia Score).
• Recurrent stricture after at least 2 previous balloon/bougie dilation or stricturotomy sessions.
• Stricture total length ≤ 7 cm. Tandem or adjacent strictures are allowed if the strictures are caused by the same underlining disease.
• Ability to undergo periodic endoscopic follow-up.
• Voluntary participation and provided written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
• Contraindication to endoscopy, anesthesia or deep sedation.
• Benign esophageal stricture due to extrinsic esophageal compression.
• Currently required chest radiation therapy.
• Malignant esophageal stricture.
• Stricture total length \> 7 cm or esophageal strictures at multiple locations where the total stricture length exceeds 7 cm
• Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, etc.
• Active erosive esophagitis.
• Present esophageal ulceration, perforation, leak, fistula, or varices.
• Concurrent gastric and/or duodenal obstruction.
• Active systemic infection.
• Allergy to paclitaxel or any components of the delivery system.
• Severe coagulation disorders or current use of anticoagulant for comorbidities.
• Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
• Received steroid injections into target stricture in the last 4 weeks

Sponsors & Collaborators

• GIE Medical: lead

Study Sites (1)

Adventista Hospital

Asunción, Paraguay

Location

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kenneth Wang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: February 24, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

PA (1)