UnknownNot Applicable

INGEST I Pilot Study

Paraguay9 participantsStarted 2019-02-24

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Incident of serious balloon dilation-related complications

Timeframe: 30 days

NCT IDNCT03885310

SponsorGIE Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12