Trial Outcomes & Findings for Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes (NCT NCT05014204)

NCT ID: NCT05014204

Last Updated: 2025-12-22

Results Overview

Number of participants experiencing device- or procedure-related serious adverse events (SAE)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 weeks post-procedure
• Results posted on: 2025-12-22

Participant Flow

Participants were recruited from 3 study sites in the US. Twenty participants were enrolled (i.e. received Endogenex treatment). Two participants did not complete the study due to patient withdrawal and physician withdrawal to relocation.

Pre-assignment did not occur in this study. All participants that met inclusion criteria and none of the exclusion criteria received treatment with the Endogenex device. At the time of the procedure, a screening endoscopy was performed on all participants to visually confirm the suitability of GI anatomy and excluding any participants with anatomy that met exclusion or preclude operator's ability to safely complete the treatment.

Participant milestones

Measure	Interventional Arm- Endogenex (PEF) Treatment Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Interventional Arm- Endogenex (PEF) Treatment Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

Baseline characteristics by cohort

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Age, Customized Age	54.4 years STANDARD_DEVIATION 7.8 • n=18 Participants
Sex: Female, Male Female	5 Participants n=18 Participants
Sex: Female, Male Male	15 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants
Race (NIH/OMB) White	20 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
HbA1c (%)	8.3 % STANDARD_DEVIATION 0.54 • n=18 Participants
Duration of Diabetes (years)	6.7 years STANDARD_DEVIATION 2 • n=18 Participants
BMI (kg/m²)	32.4 kg/m² STANDARD_DEVIATION 4.3 • n=18 Participants
Weight (lbs)	224 lbs STANDARD_DEVIATION 39 • n=18 Participants

PRIMARY outcome

Timeframe: 12 weeks post-procedure

Population: Primary endpoint was performed at 12 weeks. At the 12 weeks, data from all 20 participants were available. Two participants exited the study at the 24 week visit, resulting in the 18 participants completing the study at 48 weeks.

Number of participants experiencing device- or procedure-related serious adverse events (SAE)

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)	0 Number of Participants with related SAE

SECONDARY outcome

Timeframe: at 4,12, 24, and 48 Weeks Post Procedure

Population: Two participants were exited from the study by 24 weeks

Mean HbA1c by Post Procedure Follow-up Visits

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Mean HbA1c by Follow-up Visit Mean HbA1c at Week 4 Post Procedure	7.2 HbA1c % Standard Deviation 0.7
Mean HbA1c by Follow-up Visit Mean HbA1c at Week 12 Post Procedure	6.7 HbA1c % Standard Deviation 0.7
Mean HbA1c by Follow-up Visit Mean HbA1c at Week 24 Post Procedure	6.9 HbA1c % Standard Deviation 1.1
Mean HbA1c by Follow-up Visit Mean HbA1c at Week 36 Post Procedure	7.0 HbA1c % Standard Deviation 0.7
Mean HbA1c by Follow-up Visit Mean HbA1c at Week 48 Post Procedure	7.2 HbA1c % Standard Deviation 0.8

SECONDARY outcome

Timeframe: Follow-up at 4,12, 24, 36, and 48 weeks post procedure

Population: Two participants were exited from the study by 24 weeks.

Mean Fasting Plasma Glucose (FPG) at Post Procedure Follow-up Visit

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Mean Fasting Plasma Glucose (FPG) by Visit Mean FPG at Week 4 post procedure	140.1 mg/dL Standard Deviation 28.6
Mean Fasting Plasma Glucose (FPG) by Visit Mean FPG at Week 12 post procedure	155.7 mg/dL Standard Deviation 28.8
Mean Fasting Plasma Glucose (FPG) by Visit Mean FPG at Week 24 post procedure	155.9 mg/dL Standard Deviation 42.7
Mean Fasting Plasma Glucose (FPG) by Visit Mean FPG at Week 36 post procedure	150.8 mg/dL Standard Deviation 24.2
Mean Fasting Plasma Glucose (FPG) by Visit Mean FPG at Week 48 at post procedure	161.6 mg/dL Standard Deviation 37.0

SECONDARY outcome

Timeframe: Follow-up at 4,12, 24, 36, and 48 weeks post procedure

Population: Two participants were exited by 24 Weeks

Mean weight by Post Procedure Follow-up Visit

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Mean Weight by Follow-up Visit Mean Weight at Week 4 Post Procedure	215.6 lbs Standard Deviation 38.1
Mean Weight by Follow-up Visit Mean Weight at Week 12 Post Procedure	209.3 lbs Standard Deviation 36.1
Mean Weight by Follow-up Visit Mean Weight at Week 24 Post Procedure	214.9 lbs Standard Deviation 40.3
Mean Weight by Follow-up Visit Mean Weight at Week 36 Post Procedure	213.3 lbs Standard Deviation 41.1
Mean Weight by Follow-up Visit Mean Weight at Week 48 Post Procedure	217.8 lbs Standard Deviation 41.7

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of procedure

Percentage of participants with successful DMR procedure

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Procedural Success	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of procedure

Time between catheter insertion to catheter removal

Outcome measures

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 Participants Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Procedural Time	82.9 minutes Standard Deviation 20.1

Adverse Events

Interventional Arm- Endogenex (PEF) Treatment

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 participants at risk Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Renal and urinary disorders Nephrolithiasis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Hepatobiliary disorders Acute cholecystitis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Hepatobiliary disorders Cholecystectomy	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks

Other adverse events

Measure	Interventional Arm- Endogenex (PEF) Treatment n=20 participants at risk Participants meeting inclusion and not meeting exclusion were treated with the Endogenex device. The Endogenex device is designed to induce duodenal mucosal regeneration using pulsed electric field via non-surgical, endoscopic approach.
Injury, poisoning and procedural complications Procedural Dizziness	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Rib Fracture	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Skin and subcutaneous tissue disorders Skin Papilloma	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
General disorders Toothache	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Skin and subcutaneous tissue disorders Ulcerative Hyperkeratosis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Vomitting	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Injury, poisoning and procedural complications Lip Swelling	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Vascular disorders Orthostatic Hypertension	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Upper abdominal Pain	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Skin and subcutaneous tissue disorders CGM application site bleed	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Back Pain	10.0% 2/20 • Number of events 3 • Enrollment through study completion at 48 weeks
Infections and infestations Conjunctivitis	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Constipation	20.0% 4/20 • Number of events 4 • Enrollment through study completion at 48 weeks
Infections and infestations COVID-19	15.0% 3/20 • Number of events 3 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Vascular disorders Dizziness	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Duodenitis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Eructation	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Gastroenteritis	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Gastroesophageal Reflux Disease	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Vascular disorders Hemmorrhoids	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Infections and infestations Influenza like illness	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Limb Injury	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Injury, poisoning and procedural complications Lip Injury	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Meniscus Injury	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Infections and infestations Nasopharyngititis	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Esophagititis	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Infections and infestations Onychomycosis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Oropharyngeal Pain	70.0% 14/20 • Number of events 14 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Pain in Extremity	10.0% 2/20 • Number of events 2 • Enrollment through study completion at 48 weeks
Gastrointestinal disorders Pharyngititis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Musculoskeletal and connective tissue disorders Plantar Facititis	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polypectomy	5.0% 1/20 • Number of events 1 • Enrollment through study completion at 48 weeks

Additional Information

Chris Sorli, CMO

Endogenex

Phone: (763) 251-6820

Email: csorli@endogenex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60